PATH medical GmbH

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Filters

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) (10) Cushion, Earphone (For Audiometric Testing) (ETT) (4) Audiometer (EWO) (2)

Premarket Exempt

No Yes

Clear

1077 EARTIP 5MM BLUE 100 PCS - 04260223145322 Catalog Number :

Device Class : 1

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ, ETT

Prescription Use : Yes

Device Count : 100

1077 EARTIP 6-9MM BLUE 100 PCS - 04260223145339 Catalog Number :

Device Class : 1

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ, ETT

Prescription Use : Yes

Device Count : 100

1077 EARTIP 12-16 BLUE 100 PCS - 04260223145346 Catalog Number :

Device Class : 1

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ, ETT

Prescription Use : Yes

Device Count : 100

1077 EARTIP 8-11 TRANS 100 PCS - 04260223145353 Catalog Number :

Device Class : 1

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ, ETT

Prescription Use : Yes

Device Count : 100

Sentiero Diagnostic - 04260223145360 Catalog Number :

Device Description : Sentiero Diagnostic TEOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773 Sentiero Diagnostic TEOAE SetContent:1. Case AN1005032. Inlay Sentiero AN1006773. USB data cable AN1000894. Sentiero Diagnostic device with touchscreen AN1000985. Probe EP-DP Path long AN100028-US6. TEOAE Software AN1001097. Software label printer AN1004148. 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. AN1001169. Accessory box Sentiero Combo AN10026110. 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 - 04260223145377 Catalog Number :

Device Description : Sentiero Screening2 Device with Touchscreen

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : Yes

Device Count : 1

ALGO 7i - 04260223145414 Catalog Number : A7i-101049

Device Description : ALGO 7i Newborn Hearing Screener

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

ALGO 7i Set 1 - 04260223145421 Catalog Number : A7i-101127

Device Description : ALGO 7i Base Kit containing:1x 101049 ALGO 7i1x 101121 ALGO7i Multidata Cable1x ALGO 7i Base Kit containing:1x 101049 ALGO 7i1x 101121 ALGO7i Multidata Cable1x 100524 Power Supply1x 100525-EU Power Supply Adapter EU1x 100525-US Power Supply Adapter US1x 100525-UK Power Supply Adapter UK1x 100525-AUS Power Supply Adapter AUS1x 101092-E ALGO 7i Basinet Hook1x 101100-E ALGO 7i Check Kit1x 101124-EN ALGO 7i User Manual1x 101118 USB Stick1x 100418 USB Cable1x 101201 ALGO 7i Backback Set

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

ALGO 7i ATA Cable short - 04260223145469 Catalog Number : A7i-101003

Device Description : ALGO 7i ATA Cable, 36 Inch

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

ALGO 7i ATA Cable long - 04260223145476 Catalog Number : A7i-101004

Device Description : ALGO 7i ATA Cable 72 inch

Device Class : 2

Duns Number: 551540334

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

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