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

Stimulator, Auditory, Evoked Response (GWJ) (9) Audiometer (EWO) (6) Cable, Electrode (IKD) (1) Tester, Auditory Impedance (ETY) (1)

Premarket Exempt

No Yes

Clear

1077 ALPHA DPOAE PROBE - 04260223141379 Catalog Number :

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

1077 EAR COUPLER CABLE - 04260223141386 Catalog Number :

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

1077 ABR ELECTRODE CABLE - 04260223141393 Catalog Number :

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : IKD

Prescription Use : Yes

Device Count : 1

1077, ECC FOR EARHUGS - 04260223141409 Catalog Number :

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

Sentiero Screening - 04260223141416 Catalog Number :

Device Description : Sentiero Screening OAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. Sentiero Screening OAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Screening device with touchscreen AN100098-S5. Probe EP-DP Path long AN100028-US6. DPOAE Quick Software AN100110-Quick7. FMDPOAE Software AN1005368. Software label printer AN1004149. Accessory box Sentiero Screening AN10067610. 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 Screening - 04260223141423 Catalog Number :

Device Description : Sentiero Screening OAE + Audiometry SetContent:1. Case AN1005032. Inlay Sentier Sentiero Screening OAE + Audiometry SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Screening device with touchscreen AN100098-S5. Headphone HB7 / DD-45 AN100306-US6. Probe EP-DP Path long AN100028-US7. Pure Tone Audiometer Class 4A AN1006538. DPOAE Quick Software AN100110-Quick9. FMDPOAE Software AN10053610. Software label printer AN10041411. Accessory box Sentiero Screening AN10067612. 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 Diagnostic - 04260223141430 Catalog Number :

Device Description : Sentiero Diagnostic OAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. Sentiero Diagnostic OAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Diagnostic device with touchscreen AN1000985. Probe EP-DP Path long AN100028-US6. DPOAE Software AN1001107. FMDPOAE Software AN1005368. DPHiRES Software AN1005379. Software label printer AN10041410. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN10011611. Accessory Box Sentiero Combo AN100261 12. Power supply Sentiero AN101013+AN100993-USA

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

Sentiero Diagnostic - 04260223141447 Catalog Number :

Device Description : Sentiero Diagnostic OAE Audiometrie SetContent:1. Case AN1005032. Inlay Sentiero Sentiero Diagnostic OAE Audiometrie SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Diagnostic device with touchscreen AN1000985. Probe EP-DP Path long AN100028-US 6. Headphone HB7 / DD-45 AN100306-US7. DPOAE Software AN1001108. PTA class 3 Software AN1001149. TEOAE Software AN10010910. DPOAE Threshold Estimation Software AN10011111. DPHiRES Software AN10053712. FMDPOAE Software AN10053613. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN10011614. Software label printer AN10041415. Accessory box Sentiero Combo AN10026116. Power supply Sentiero AN101013+AN100993-USA

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

Sentiero Diagnostic - 04260223141454 Catalog Number :

Device Description : Sentiero Diagnostic OAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. Sentiero Diagnostic OAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Diagnostic device with touchscreen AN1000985. Probe EP-DP Path long AN100028-US6. Probe EP-VIP AN100539-US7. TEOAE Software AN1001098. DPOAE Software AN1001109. DPHiRES Software AN10053710. FMDPOAE Software AN10053611. DPOAE Threshold Estimation Software AN10011112. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN10011613. Software label printer AN10041414. Accessory box Sentiero Combo AN10026115. 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 Desktop Screening - 04260223141478 Catalog Number :

Device Description : Sentiero Desktop Screening Set US1Sentiero Desktop Screening Set Tymp with IPSI Sentiero Desktop Screening Set US1Sentiero Desktop Screening Set Tymp with IPSI ReflexContent:1. Sentiero Desktop (Tymp Screening) AN100434-SB2. USB data cable AN1004183. Probe EP-TY long AN100188-US4. FW Screening Tymp class 2 AN1005605. Software label printer AN1004146. Accessory box for Tymp probe AN1005877. Accessory box AB08 AN100734-P8. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally9. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally10. Test cavity tymp AN100549

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ, ETY

Prescription Use : Yes

Device Count : 1

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