FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERSONAL ROMEAR
K Number: K823588
·
Decision Apr 27, 1983
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
1
Review Days
142
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Basic Information
- Device Name
- PERSONAL ROMEAR
- K Number
- K823588
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Romear Mfg., Inc.
- Date Received
- December 6, 1982
- Decision Date
- April 27, 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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