Sonic Innovations, Inc.

Address:2501 Cottontail Lane,Somerset,NJ,08873,US

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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

Hearing aid, air conduction with wireless technology (OSM) (10)

Premarket Exempt

No Yes

Clear

Sonic - 05707131304995 Catalog Number :

Device Description : SPEAKER UNIT 1R STANDARD CLASSICFIT

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131305008 Catalog Number :

Device Description : SPEAKER UNIT 2R STANDARD CLASSICFIT

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131305015 Catalog Number :

Device Description : SPEAKER UNIT 3R STANDARD CLASSICFIT

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131315724 Catalog Number :

Device Description : ET100 MNR, 2.4G NFM PB BE ENCHANT 100

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131315731 Catalog Number :

Device Description : ET100 MNR, 2.4G NFM PB TP ENCHANT 100

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131315748 Catalog Number :

Device Description : ET100 MNR, 2.4G NFM PB BR ENCHANT 100

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131315755 Catalog Number :

Device Description : ET100 MNR, 2.4G NFM PB GR ENCHANT 100

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131315762 Catalog Number :

Device Description : ET100 MNR, 2.4G NFM PB DG ENCHANT 100

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131315779 Catalog Number :

Device Description : ET100 MNR, 2.4G NFM PB BL ENCHANT 100

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131329967 Catalog Number :

Device Description : RC-A, 2.4G DG SONIC

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

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