PATH medical GmbH

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Audiometer (EWO) (9) Stimulator, Auditory, Evoked Response (GWJ) (9) Tester, Auditory Impedance (ETY) (4)

Premarket Exempt

No Yes

Clear

Sentiero Advanced - 04260223145223 Catalog Number :

Device Description : Sentiero Advanced ABR and DPOAE Screening SetContent:1. Case AN1005032. Inlay Se Sentiero Advanced ABR and DPOAE Screening SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 1004685. Sentiero Advanced device with touchscreen AN1003606. ABR electrode cable AN1003077. Probe EP-LT AN1010218. Accessory box EP-LT AN1010439. ABR Quick SW AN100337-Quick10. DPOAE Quick SW AN100110-Quick11. FMDPOAE SW AN10053612. Mira PC Patient Management SW AN10011613. Label Printer SW AN10041414. Power Supply Sentiero Advanced US AN101016+AN100993-USA

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ, EWO

Prescription Use : Yes

Device Count : 1

Sentiero Advanced - 04260223145230 Catalog Number :

Device Description : Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening SetContent:1. Case Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 1004685. Sentiero Advanced device with touchscreen AN1003606. ABR electrode cable AN1003077. Headphone DD-45 AN1003068. Probe EP-DP Path long AN100028-US9. Accessory box Sentiero Combo AN10026110. ABR Quick SW AN100337-Quick11. TEOAE Quick SW AN100109-Quick12. DPOAE Quick SW AN100110-Quick13. FMDPOAE SW AN10053614. Tymp Class 2 SW AN10056015. Audio Class 4 Advanced SW AN10065316. Mira PC Patient Management SW AN10011617. Label Printer SW AN10041418. Power Supply Sentiero Advanced US AN101016+AN100993-USA19. Tympanometry add-on TY-MA AN10094720. Accessory box AB08 AN100734-P21. Tympanometry cavity AN10054922. Probe tip small PT-S AN100014-W (3 pcs.)23. Probe tip medium PT-A AN100013 (5 pcs.)

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ, EWO, ETY

Prescription Use : Yes

Device Count : 1

Sentiero Advanced - 04260223145247 Catalog Number :

Device Description : Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening SetContent:1. Case Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 1004685. Sentiero Advanced device with touchscreen AN1003606. ABR electrode cable AN1003077. Headphone DD-45 AN1003068. Probe EP-LT AN1010219. Accessory box EP-LT AN10104310. ABR Quick SW AN100337-Quick11. TEOAE Quick SW AN100109-Quick12. DPOAE Quick SW AN100110-Quick13. FMDPOAE SW AN10053614. Tymp Class 2 SW AN10056015. Audio Class 4 Advanced SW AN10065316. Mira PC Patient Management SW AN10011617. Label Printer SW AN10041418. Power Supply Sentiero Advanced US AN101016+AN100993-USA19. Tympanometry add-on TY-MA AN10094720. Accessory box AB08 AN100734-P21. Tympanometry cavity AN10054922. Probe tip small PT-S AN100014-W (3 pcs.)23. Probe tip medium PT-A AN100013 (5 pcs.)

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ, EWO, ETY

Prescription Use : Yes

Device Count : 1

Sentiero Advanced - 04260223145254 Catalog Number :

Device Description : Sentiero Advanced ABR and TEOAE Screening SetContent:1. Case AN1005032. Inlay Se Sentiero Advanced ABR and TEOAE Screening SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 1004685. Sentiero Advanced device with touchscreen AN1003606. ABR electrode cable AN1003077. Probe EP-DP Path long AN100028-US8. Accessory box Sentiero Combo AN1002619. ABR Quick SW AN100337-Quick10. TEOAE Quick SW AN100109-Quick11. Mira PC Patient Management SW AN10011612. Label Printer SW AN10041413. Power Supply Sentiero Advanced US AN101016+AN100993-USA

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ, EWO

Prescription Use : Yes

Device Count : 1

Sentiero Advanced - 04260223145261 Catalog Number :

Device Description : 100340-SC-ATSentiero Advanced ABR and TEOAE Screening SetContent:1. Case AN10050 100340-SC-ATSentiero Advanced ABR and TEOAE Screening SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 1004685. Sentiero Advanced device with touchscreen AN1003606. ABR electrode cable AN1003077. Probe EP-LT AN1010218. Accessory box EP-LT AN1010439. ABR Quick SW AN100337-Quick10. TEOAE Quick SW AN100109-Quick11. Mira PC Patient Management SW AN10011612. Label Printer SW AN10041413. Power Supply Sentiero Advanced US AN101016+AN100993-USA

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ, EWO

Prescription Use : Yes

Device Count : 1

Sentiero Advanced - 04260223145278 Catalog Number :

Device Description : Sentiero Advanced Starter KitContent:1. Case AN1005032. Inlay Sentiero AN1006773 Sentiero Advanced Starter KitContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Advanced device with touchscreen AN1003605. Label Printer SW AN1004146. Power Supply Sentiero Advanced US AN101016+AN100993-USA

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ, EWO

Prescription Use : Yes

Device Count : 1

Senti Desktop Flex - 04260223145285 Catalog Number :

Device Description : Senti Desktop Flex Screening SetContent:1. Case AN1005032. Inlay Sentiero AN1003 Senti Desktop Flex Screening SetContent:1. Case AN1005032. Inlay Sentiero AN1003853. Senti Desktop Flex device AN1004334. Headphone DD-45 AN1003065. FW Labelprinter AN1004146. FW Pure Tone Audiometer Class 4 Advanced AN1006537. Power supply AN100524 + AN100525-USA or AN101360 + 101251-USA optionally8. USB data cable AN100418

Device Class : 2

Duns Number: 551540334

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : Yes

Device Count : 1

Sentiero Desktop Diagnostic - 04260223145292 Catalog Number :

Device Description : Sentiero Desktop Easy Diag SetContent:1. Sentiero Desktop (Tymp Diagnostic) AN10 Sentiero Desktop Easy Diag SetContent:1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG2. USB data cable AN1004183. Headphone DD-45 AN1003064. Probe EP-TY long AN100188-US5. FW Screening Tymp class 1 AN1005616. Mira PC Patient Management Software7. Software label printer AN1004148. Accessory box for Tymp probe AN1005879. Accessory box AB08 AN100734-P10. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally11. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally12. Test cavity tymp AN100549

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ, ETY

Prescription Use : Yes

Device Count : 1

Sentiero Desktop Diagnostic - 04260223145308 Catalog Number :

Device Description : Sentiero Desktop Diagnostic Starter KitContent:1. Sentiero Desktop (Tymp Diagnos Sentiero Desktop Diagnostic Starter KitContent:1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG2. USB data cable AN1004183. Software label printer AN1004144. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally5. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ, ETY

Prescription Use : Yes

Device Count : 1

Ear Coupler Set - 04260223145315 Catalog Number :

Device Description : Ear Coupler Set (5 pcs.)

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 5

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