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

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

Premarket Exempt

No Yes

Clear

Vemp Monitor - 05713315008801 Catalog Number :

Device Description : Vemp Monitor

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

AccuScreen - 05713315008818 Catalog Number :

Device Description : 1077 AccuScreen TE

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

AccuScreen - 05713315008825 Catalog Number :

Device Description : 1077 AccuScreen DP

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

AccuScreen - 05713315008832 Catalog Number :

Device Description : 1077 AccuScreen TE/DP

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

AccuScreen - 05713315008849 Catalog Number :

Device Description : 1077 AccuScreen ABR

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

1077 AccuScreen - 05713315008856 Catalog Number :

Device Description : 1077 MADSEN AccuScreen, ABR/TE including standard accessories incl. probe

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

AccuScreen - 05713315008863 Catalog Number :

Device Description : 1077 AccuScreen ABR/DP

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

Accuscreen - 05713315008870 Catalog Number :

Device Description : 1077 AccuScreen ABR/TE/DP

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

Accuscreen - 05713315008887 Catalog Number :

Device Description : 1077 AccuScreen Lite TE

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

AccuScreen - 05713315008894 Catalog Number :

Device Description : 1077 AccuScreen Lite DP

Device Class : 2

Duns Number: 306633756

Premarket Exempt : No

Product Code : GWJ

Prescription Use : Yes

Device Count : 1

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