FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POST-AURICULAR HEARING AID MODEL PE 600PPCH
K Number: K844862
·
Decision Apr 8, 1985
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
1366
Applicant Total
31
Review Days
115
Basic Information
- Device Name
- POST-AURICULAR HEARING AID MODEL PE 600PPCH
- K Number
- K844862
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- PHONIC EAR, INC.
- Date Received
- December 14, 1984
- Decision Date
- April 8, 1985
- 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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