INTRICON CORPORATION

INTRICON CORPORATION

Address:1260 Red Fox Rd,ARDEN HILLS,MN,55112,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

Yes

Clear

IntriCon - 00858177007007 Catalog Number : 93136

Device Description : Wireless Hearing Aid

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

IntriCon - 00858177007014 Catalog Number : 93153

Device Description : Hearing Aid Remote Control

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

LifeEar - 00858177007021 Catalog Number : 93234

Device Description : Wireless Hearing Aid

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

IntriCon - 00858177007038 Catalog Number : 93218

Device Description : Wireless Hearing Aid

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

IntriCon - 00858177007045 Catalog Number : 93211

Device Description : Wireless Hearing Aid

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

hi Health Innovations - 00858177007052 Catalog Number : 93232-000, 93232-001

Device Description : Wireless Hearing Aid-001, Metallic Gray-002, Metallic Gold

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

hi Health Innovations - 00858177007069 Catalog Number : 22957

Device Description : IOS Remote Control App

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

hi Health Innovations - 00858177007076 Catalog Number : 22724

Device Description : Hearing Aid Fitting Software

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

hi Health Innovations - 00858177007083 Catalog Number : 93237-000

Device Description : Hearing Aid Enhanced Audio Device

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

hi Health - 00858177007090 Catalog Number : 93299-000, 001

Device Description : Wireless Hearing Aid

Device Class : 2

Duns Number: 002345767

Premarket Exempt : Yes

Product Code : OSM

Prescription Use : Yes

Device Count : 1

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