BEHIND-THE-EAR MODEL SERIES 123— 510(k) K822387
Substantially EquivalentDanavox, Inc.
FDA 510(k) clearance K822387 for BEHIND-THE-EAR MODEL SERIES 123, Substantially Equivalent on 1982-08-19. Applicant: Danavox, Inc.. Device class: 1.
Clearance details
- Applicant
- Danavox, 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
- Mchenry, IL, US
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