FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POCKETALKER PRO
K Number: K954748
·
Decision Nov 22, 1995
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
6
Applicant Total
4
Review Days
37
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Basic Information
- Device Name
- POCKETALKER PRO
- K Number
- K954748
- 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
- October 16, 1995
- Decision Date
- November 22, 1995
- Product Code
- LZI
- 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 |
|---|---|---|---|
| LZI | Device, Assistive Listening | FDA class 2 | Ear, Nose, Throat |
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