Interacoustics A/S

Address:Audiometer Alle 1,Middelfart Syddanmark,DK

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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

Electrode, Cutaneous (GXY) (5) Audiometer (EWO) (4) Calibrator, Hearing Aid / Earphone And Analysis Systems (ETW) (1) Nystagmograph (GWN) (1) Stimulator, Auditory, Evoked Response (GWJ) (1)

Premarket Exempt

No Yes

Clear

Interacoustics - 05711117190823 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : No

Product Code : GWJ, EWO

Prescription Use : No

Device Count : 1

Interacoustics - 05711117195989 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : No

Product Code : GWN

Prescription Use : No

Device Count : 1

Interacoustics - 05711117196313 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

Interacoustics - 05711117197877 Catalog Number :

Device Description : Audiometer

Device Class : 2

Duns Number: 306308354

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

Interacoustics - 05711117198218 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : Yes

Product Code : ETW, EWO

Prescription Use : No

Device Count : 1

Sanibel - 05711117199321 Catalog Number :

Device Class :

Duns Number: 306308354

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 3

Sanibel - 05711117199338 Catalog Number :

Device Class :

Duns Number: 306308354

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 5

Sanibel - 05711117199345 Catalog Number :

Device Class :

Duns Number: 306308354

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 3

Sanibel - 05711117199352 Catalog Number :

Device Description : Pouch of 60 electrodes

Device Class :

Duns Number: 306308354

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 5

Sanibel - 05711117199369 Catalog Number :

Device Class :

Duns Number: 306308354

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 3

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