E1 SERIES HEARING AID— 510(k) K802324
Substantially EquivalentWestern Advanced Technology, Inc.
FDA 510(k) clearance K802324 for E1 SERIES HEARING AID, Substantially Equivalent on 1980-10-10. Applicant: Western Advanced Technology, Inc.. Device class: 1.
Clearance details
- Applicant
- Western Advanced Technology, 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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