FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
K Number: K970687
·
Decision May 2, 1997
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
31
Applicant Total
4
Review Days
67
Basic Information
- Device Name
- WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
- K Number
- K970687
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3320
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Williams Sound, LLC
- Date Received
- February 24, 1997
- Decision Date
- May 2, 1997
- Product Code
- EPF
- 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 |
|---|---|---|---|
| EPF | Hearing Aid, Group And Auditory Trainer | FDA class 2 | Ear, Nose, Throat |
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