MODEL HP HEARING AID— 510(k) K862036
Substantially EquivalentFine-Tune
FDA 510(k) clearance K862036 for MODEL HP HEARING AID, Substantially Equivalent on 1986-06-23. Applicant: Fine-Tune. Device class: 1.
Clearance details
- Applicant
- Fine-Tune
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deltona, FL, US
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