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 - 05707131241948 Catalog Number :

Device Description : FL80 MNR, VC PS BL FLIP 80

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131241955 Catalog Number :

Device Description : FL60 MNR, VC PS DG FLIP 60

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131241962 Catalog Number :

Device Description : FL60 MNR, VC PS DB FLIP 60

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131241979 Catalog Number :

Device Description : FL60 MNR, VC PS BL FLIP 60

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131271303 Catalog Number :

Device Description : SOUNDGATE 2.0, SONIC DG

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Sonic - 05707131304940 Catalog Number :

Device Description : SPEAKER UNIT 0L STANDARD CLASSICFIT

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131304957 Catalog Number :

Device Description : SPEAKER UNIT 1L STANDARD CLASSICFIT

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131304964 Catalog Number :

Device Description : SPEAKER UNIT 2L STANDARD CLASSICFIT

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131304971 Catalog Number :

Device Description : SPEAKER UNIT 3L STANDARD CLASSICFIT

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

Sonic - 05707131304988 Catalog Number :

Device Description : SPEAKER UNIT 0R STANDARD CLASSICFIT

Device Class : 2

Duns Number: 968696919

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

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