FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MENTOR TONO-PEN 3
K Number: K964312
·
Decision Nov 26, 1996
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
55
Applicant Total
4
Review Days
28
Basic Information
- Device Name
- MENTOR TONO-PEN 3
- K Number
- K964312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MENTOR OPHTHALMICS, INC.
- Date Received
- October 29, 1996
- Decision Date
- November 26, 1996
- Product Code
- HKY
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HKY | Tonometer, Manual | FDA class 2 | Ophthalmic |
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