FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LISTENAIDER II
K Number: K952057
·
Decision Jun 21, 1995
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
6
Applicant Total
3
Review Days
50
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Basic Information
- Device Name
- LISTENAIDER II
- K Number
- K952057
- 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
- National Hearing Aid Dist., Inc.
- Date Received
- May 2, 1995
- Decision Date
- June 21, 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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