HAE 2— 510(k) K942831
Substantially EquivalentHearing Aid Express
FDA 510(k) clearance K942831 for HAE 2, Substantially Equivalent on 1994-07-20. Applicant: Hearing Aid Express. Device class: 1.
Clearance details
- Applicant
- Hearing Aid Express
- 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
- Bellaire, TX, US
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