FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FACEPLATE ASSEMBLY
K Number: K974219
·
Decision Feb 20, 1998
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
23
Applicant Total
5
Review Days
102
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Basic Information
- Device Name
- FACEPLATE ASSEMBLY
- K Number
- K974219
- 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
- Finetone Hearing Instruments
- Date Received
- November 10, 1997
- Decision Date
- February 20, 1998
- 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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