FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AAHS HEARING AID
K Number: K925103
·
Decision Nov 6, 1992
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
1366
Applicant Total
1
Review Days
29
Basic Information
- Device Name
- AAHS HEARING AID
- K Number
- K925103
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- AMERICAN HEARING SYSTEMS, INC.
- Date Received
- October 8, 1992
- Decision Date
- November 6, 1992
- Product Code
- ESD
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | FDA class 1 | Ear, Nose, Throat |
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