BEHIND THE EAR ASP-BB— 510(k) K833334
Substantially EquivalentOmni Hearing Systems
FDA 510(k) clearance K833334 for BEHIND THE EAR ASP-BB, Substantially Equivalent on 1983-11-14. Applicant: Omni Hearing Systems. Device class: 1.
Clearance details
- Applicant
- Omni Hearing Systems
- 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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