FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IN THE EAR HEARING AID
K Number: K915711
·
Decision Jun 10, 1992
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
1
Review Days
188
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Basic Information
- Device Name
- IN THE EAR HEARING AID
- K Number
- K915711
- 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
- Zenith-Omni H.C., Inc.
- Date Received
- December 5, 1991
- Decision Date
- June 10, 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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