FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONPHAR-SCHIOETZ TONOMETER
K Number: K813619
·
Decision Feb 24, 1982
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
55
Applicant Total
122
Review Days
57
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Basic Information
- Device Name
- CONPHAR-SCHIOETZ TONOMETER
- K Number
- K813619
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Conphar, Inc.
- Date Received
- December 29, 1981
- Decision Date
- February 24, 1982
- 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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| K821298 | BACKHAUS CLAMP, 3 1/2 | May 28, 1982 | Substantially Equivalent |
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| K821275 | MAYO SCISSOR STRAIGHT 5 1/2 | May 28, 1982 | Substantially Equivalent |
| K821284 | ADSON FORCEPS 4 3/4 | May 28, 1982 | Substantially Equivalent |
| K821248 | ROCHESTER PEAN FORCEPS | May 28, 1982 | Substantially Equivalent |