PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II— 510(k) K893432
Substantially EquivalentElectone, Inc.
FDA 510(k) clearance K893432 for PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II, Substantially Equivalent on 1989-08-04. Applicant: Electone, Inc.. Device class: 1.
Clearance details
- Applicant
- Electone, Inc.
- 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
- Winter Park, FL, US
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