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) (10)

Premarket Exempt

Yes

Clear

UNITRON - 07613389048919 Catalog Number : 050-6062-P7

Device Description : T Max SP 700 (pewter)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389048926 Catalog Number : 050-6062-P8

Device Description : T Max SP 700 (charcoal)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389048933 Catalog Number : 050-6063-P2

Device Description : T Max SP 800 (amber)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389048940 Catalog Number : 050-6063-P4

Device Description : T Max SP 800 (espresso)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389048957 Catalog Number : 050-6063-P6

Device Description : T Max SP 800 (platinum)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389048964 Catalog Number : 050-6063-P7

Device Description : T Max SP 800 (pewter)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : OSM, KLW

Prescription Use : No

Device Count : 1

UNITRON - 07613389048971 Catalog Number : 050-6063-P8

Device Description : T Max SP 800 (charcoal)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389048988 Catalog Number : 050-6064-P2

Device Description : T Max SP Pro (amber)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389048995 Catalog Number : 050-6064-P4

Device Description : T Max SP Pro (espresso)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

UNITRON - 07613389049008 Catalog Number : 050-6064-P6

Device Description : T Max SP Pro (platinum)

Device Class : 2

Duns Number: 243202080

Premarket Exempt : Yes

Product Code : KLW, OSM

Prescription Use : No

Device Count : 1

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