COMFORTONE PHS— 510(k) K960741
Substantially EquivalentComfortone America'S Value Hearing Aid Line
FDA 510(k) clearance K960741 for COMFORTONE PHS, Substantially Equivalent on 1996-05-07. Applicant: Comfortone America'S Value Hearing Aid Line. Device class: 1.
Clearance details
- Applicant
- Comfortone America'S Value Hearing Aid Line
- 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
- Wichita, KS, US
Recent devices under product code ESD
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