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

Nystagmograph (GWN) (5) Apparatus, Vestibular Analysis (LXV) (1) Audiometer (EWO) (1) Cushion, Earphone (For Audiometric Testing) (ETT) (1) Stimulator, Caloric-Air (KHH) (1) Stimulator, Caloric-Water (ETP) (1)

Premarket Exempt

No Yes

Clear

Interacoustics - 05711117199567 Catalog Number :

Device Class : 1

Duns Number: 306308354

Premarket Exempt : Yes

Product Code : KHH

Prescription Use : No

Device Count : 1

Interacoustics - 05711117199574 Catalog Number :

Device Class : 1

Duns Number: 306308354

Premarket Exempt : Yes

Product Code : ETP

Prescription Use : No

Device Count : 1

Interacoustics - 05711117219098 Catalog Number :

Device Class : U

Duns Number: 306308354

Premarket Exempt : No

Product Code : LXV

Prescription Use : No

Device Count : 1

Sanibel Supply - 05711117221848 Catalog Number :

Device Class :

Duns Number: 306308354

Premarket Exempt : Yes

Product Code : ETT

Prescription Use : No

Device Count : 2

Interacoustics - 05711117223095 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

Interacoustics - 05711117223538 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : No

Product Code : GWN

Prescription Use : No

Device Count : 1

Interacoustics - 05711117223545 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : No

Product Code : GWN

Prescription Use : No

Device Count : 1

Interacoustics - 05711117223552 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : No

Product Code : GWN

Prescription Use : No

Device Count : 1

Interacoustics - 05711117223569 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : No

Product Code : GWN

Prescription Use : No

Device Count : 1

Interacoustics - 05711117223576 Catalog Number :

Device Class : 2

Duns Number: 306308354

Premarket Exempt : No

Product Code : GWN

Prescription Use : No

Device Count : 1

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