BEHIND-THE-EAR HEARING AID MODEL 48 AGCI— 510(k) K892338
Substantially EquivalentQualitone
FDA 510(k) clearance K892338 for BEHIND-THE-EAR HEARING AID MODEL 48 AGCI, Substantially Equivalent on 1989-08-03. Applicant: Qualitone. Device class: 1.
Clearance details
- Applicant
- Qualitone
- 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
- Minneapolis, MN, US
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