audifon Tinnitus-Module— 510(k) K171243
Substantially EquivalentAudiofon USA, Inc.
FDA 510(k) clearance K171243 for audifon Tinnitus-Module, Substantially Equivalent on 2017-10-19. Applicant: Audiofon USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Audiofon USA, Inc.
- Product code
- Code KLW
- Device class
- Class 2
- Regulation
- 21 CFR 874.3400
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Debary, FL, US
Recent devices under product code KLW
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