FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RELIABLE
K Number: K834479
·
Decision Jul 11, 1984
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
23
Applicant Total
1
Review Days
204
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Basic Information
- Device Name
- RELIABLE
- K Number
- K834479
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Reliable Hearing Aide
- Date Received
- December 20, 1983
- Decision Date
- July 11, 1984
- Product Code
- LRB
- 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 |
|---|---|---|---|
| LRB | Face Plate Hearing Aid | FDA class 1 | Ear, Nose, Throat |
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