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) (10) Masker, tinnitus (KLW) (4)

Premarket Exempt

Yes

Clear

UNITRON - 07613389049015 Catalog Number : 050-6064-P7

Device Description : T Max SP Pro (pewter)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389049022 Catalog Number : 050-6064-P8

Device Description : T Max SP Pro (charcoal)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389049091 Catalog Number : 050-6070-01

Device Description : T Max UP 500 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389049107 Catalog Number : 050-6071-01

Device Description : T Max UP 600 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

Unitron - 07613389049169 Catalog Number : 050-6060-0144

Device Description : Vista T 510 SP 13 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Unitron - 07613389049176 Catalog Number : 050-6061-0144

Device Description : Vista T 610 SP 13 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Unitron - 07613389049183 Catalog Number : 050-6062-0144

Device Description : Vista T 710 SP 13 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Unitron - 07613389049190 Catalog Number : 050-6063-0144

Device Description : Vista T 810 SP 13 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Unitron - 07613389049206 Catalog Number : 050-6064-0144

Device Description : Vista T 910 SP 13 (beige)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

Unitron - 07613389049213 Catalog Number : 050-6065-P744

Device Description : Vista T SP 13 trial (pewter)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : No

Device Count : 1

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