Unitron Hearing Division

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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) (3)

Premarket Exempt

Yes

Clear

Unitron - 07630034395174 Catalog Number : 050-5791-P644

Device Description : Vista T 610 M 312 (platinum)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Unitron - 07630034395181 Catalog Number : 050-5791-P744

Device Description : Vista T 610 M 312 (pewter)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Unitron - 07630034395211 Catalog Number : 050-5791-S244

Device Description : Vista T 610 M 312 (amber suede)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

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