Gn Otometrics A/S

Gn Otometrics A/S

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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

Calibrator, Hearing Aid / Earphone And Analysis Systems (ETW) (5) Otoscope (ERA) (4) Stimulator, Auditory, Evoked Response (GWJ) (1)

Premarket Exempt

No Yes

Clear

AccuScreen - 00571331500885 Catalog Number :

Device Description : 1077 AccuScreen ABR/TE

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

GN Otometrics A/S - 05713315000041 Catalog Number :

Device Class : 1

Duns Number: 306633756

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

GN Otometrics A/S - 05713315000065 Catalog Number :

Device Class : 1

Duns Number: 306633756

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

GN Otometrics A/S - 05713315000072 Catalog Number :

Device Class : 1

Duns Number: 306633756

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

GN Otometrics A/S - 05713315000089 Catalog Number :

Device Class : 1

Duns Number: 306633756

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

GN Otometrics A/S - 05713315000096 Catalog Number :

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : ETW

Prescription Use : No

Device Count : 1

GN Otometrics A/S - 05713315000102 Catalog Number :

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : ETW

Prescription Use : No

Device Count : 1

GN Otometrics A/S - 05713315000119 Catalog Number :

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : ETW

Prescription Use : No

Device Count : 1

GN Otometrics A/S - 05713315000126 Catalog Number :

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : ETW

Prescription Use : No

Device Count : 1

GN Otometrics A/S - 05713315000133 Catalog Number :

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : ETW

Prescription Use : No

Device Count : 1

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