FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODEL F1 HEARING AID
K Number: K823067
·
Decision Feb 1, 1983
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
2
Review Days
105
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Basic Information
- Device Name
- MODEL F1 HEARING AID
- K Number
- K823067
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Katz Hearing Aid Center
- Date Received
- October 19, 1982
- Decision Date
- February 1, 1983
- 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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Other Clearances by Katz Hearing Aid Center
| K Number | Device Name | ||
|---|---|---|---|
| K932105 | HEARING AIDS | Jun 14, 1993 | Substantially Equivalent |