FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANON TX-10 TONOMETER
K Number: K963079
·
Decision Mar 3, 1997
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
57
Applicant Total
48
Review Days
208
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Basic Information
- Device Name
- CANON TX-10 TONOMETER
- K Number
- K963079
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canon USA, Inc.
- Date Received
- August 7, 1996
- Decision Date
- March 3, 1997
- Product Code
- HKX
- 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 |
|---|---|---|---|
| HKX | Tonometer, Ac-Powered | FDA class 2 | Ophthalmic |
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