OTODYNAMICS LIMITED

Address:30-38 BEACONSFIELD RD.,HATFIELD, HERTS Hertfordshire,GB

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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

Audiometer (EWO) (5) Stimulator, Auditory, Evoked Response (GWJ) (5)

Premarket Exempt

No Yes

Clear

Otocheck - TEOAE Screener - 05060396170041 Catalog Number :

Device Class : 2

Duns Number: 235908050

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

Otocheck - TEOAE+ABR Screener - 05060396170058 Catalog Number :

Device Class : 2

Duns Number: 235908050

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

Otocheck - DPOAE Screener - 05060396170065 Catalog Number :

Device Class : 2

Duns Number: 235908050

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

Otocheck - DPOAE + ABR Screener - 05060396170072 Catalog Number :

Device Class : 2

Duns Number: 235908050

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

Otoport - DP+TE OAE Analyser - 05060396170089 Catalog Number :

Device Class : 2

Duns Number: 235908050

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

Otoport - DP+TE OAE+ABR Analyser - 05060396170096 Catalog Number :

Device Class : 2

Duns Number: 235908050

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

Otoport - Advance OAE Analyser - 05060396170119 Catalog Number :

Device Class : 2

Duns Number: 235908050

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

Otoport - Advance OAE+ABR Analyser - 05060396170126 Catalog Number :

Device Class : 2

Duns Number: 235908050

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

Otocheck - ABR Screener - 05060396170140 Catalog Number :

Device Class : 2

Duns Number: 235908050

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

Otocheck - LE TEOAE Screener - 05060396170171 Catalog Number :

Device Class : 2

Duns Number: 235908050

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

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