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) (10) Stimulator, Auditory, Evoked Response (GWJ) (10)

Premarket Exempt

No Yes

Clear

Sentiero Screening2 - 04260223145124 Catalog Number :

Device Description : Sentiero Screening2 Audio and DPOAE SetContent:1. Case AN1005032. Inlay Sentiero Sentiero Screening2 Audio and DPOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Screening2 device with touchscreen AN100098-S25. Headphone DD-45 AN1003066. Probe EP-DP Path long AN100028-US7. Audio Class4 Advanced Software AN1006538. DPOAE Quick Software AN100110-Quick9. FMDPOAE Software AN10053610. Software label printer AN10041411. Accessory box Sentiero PT-S AN10090212. Power supply Sentiero US AN101013+AN100993-USA

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

Sentiero Screening2 - 04260223145131 Catalog Number :

Device Description : Sentiero Screening2 Audio and DPOAE SetContent:1. Case AN1005032. Inlay Sentiero Sentiero Screening2 Audio and DPOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Screening2 device with touchscreen AN100098-S25. Headphone DD-45 AN1003066. Probe EP-LT AN1010217. Audio Class4 Advanced Software AN1006538. DPOAE Quick Software AN100110-Quick9. FMDPOAE Software AN10053610. Software label printer AN10041411. Accessory box EP-LT AN10104312. Power supply Sentiero US AN101013+AN100993-USA

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

Sentiero Screening2 - 04260223145148 Catalog Number :

Device Description : Sentiero Screening2 Audio and TEOAE SetContent:1. Case AN1005032. Inlay Sentiero Sentiero Screening2 Audio and TEOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Screening2 device with touchscreen AN100098-S25. Headphone DD-45 AN1003066. Probe EP-DP Path long AN100028-US7. Audio Class4 Advanced Software AN1006538. TEOAE Quick Software AN100109-Quick9. Software label printer AN10041410. Accessory box Sentiero PT-S AN10090211. Power supply Sentiero US AN101013+AN100993-USA

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

Sentiero Screening2 - 04260223145155 Catalog Number :

Device Description : Sentiero Screening2 Audio and TEOAE SetContent:1. Case AN1005032. Inlay Sentiero Sentiero Screening2 Audio and TEOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Screening2 device with touchscreen AN100098-S25. Headphone DD-45 AN1003066. Probe EP-LT AN1010217. Audio Class4 Advanced Software AN1006538. TEOAE Quick Software AN100109-Quick9. Software label printer AN10041410. Accessory box EP-LT AN10104311. Power supply Sentiero US AN101013+AN100993-USA

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

Sentiero Screening2 - 04260223145162 Catalog Number :

Device Description : Sentiero Screening2 DPOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773 Sentiero Screening2 DPOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Screening2 device with touchscreen AN100098-S25. Probe EP-DP Path long AN100028-US6. DPOAE Quick Software AN100110-Quick7. FMDPOAE Software AN1005368. Software label printer AN1004149. Accessory box Sentiero PT-S AN10090210. Power supply Sentiero US AN101013+AN100993-USA

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

Sentiero Screening2 - 04260223145179 Catalog Number :

Device Description : Sentiero Screening2 DPOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773 Sentiero Screening2 DPOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Screening2 device with touchscreen AN100098-S25. Probe EP-LT AN1010216. DPOAE Quick Software AN100110-Quick7. FMDPOAE Software AN1005368. Software label printer AN1004149. Accessory box EP-LT AN10104310. Power supply Sentiero US AN101013+AN100993-USA

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

Sentiero Screening2 - 04260223145186 Catalog Number :

Device Description : Sentiero Screening2 TEOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773 Sentiero Screening2 TEOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Screening2 device with touchscreen AN100098-S25. Probe EP-DP Path long AN100028-US6. TEOAE Quick Software AN100109-Quick7. Software label printer AN1004148. Accessory box Sentiero PT-S AN1009029. Power supply Sentiero US AN101013+AN100993-USA

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

Sentiero Screening2 - 04260223145193 Catalog Number :

Device Description : Sentiero Screening2 TEOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773 Sentiero Screening2 TEOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Screening2 device with touchscreen AN100098-S25. Probe EP-LT AN1010216. TEOAE Quick Software AN100109-Quick7. Software label printer AN1004148. Accessory box EP-LT AN1010439. Power supply Sentiero US AN101013+AN100993-USA

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

Sentiero Advanced - 04260223145209 Catalog Number :

Device Description : Sentiero Advanced Easy Diag SetContent:1. Case AN1005032. Inlay Sentiero AN10067 Sentiero Advanced Easy Diag 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. PATH Insert Earphones (PIEP) AN1008608. ABR Quick SW AN1003379. Binaural ABR SW AN10042410. ABR FFC/FS SW AN10046611. 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 - 04260223145216 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-DP Path long AN100028-US8. Accessory box Sentiero Combo AN1002619. 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

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