FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
FRIEDMANN ANALYSER 3
K Number: K914896
·
Decision Jan 23, 1992
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
0
Applicant Total
10
Review Days
84
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Basic Information
- Device Name
- FRIEDMANN ANALYSER 3
- K Number
- K914896
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1810
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clement Clarke, Inc.
- Date Received
- October 31, 1991
- Decision Date
- January 23, 1992
- Product Code
- HOK
- 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 |
|---|---|---|---|
| HOK | Screen, Tangent, Projection, Ac-Powered | FDA class 1 | Ophthalmic |
Other Clearances by Clement Clarke, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961512 | PERKINS HAND-HELD APPLANATION TONOMETER | Jul 18, 1996 | Substantially Equivalent |
| K952713 | MINI WRIGHT LR AFS | Mar 29, 1996 | Substantially Equivalent |
| K953965 | 904 SLIT LAMP | Sep 27, 1995 | Substantially Equivalent |
| K932258 | OPTICOM M600 | Jul 25, 1994 | Substantially Equivalent |
| K914126 | VMX MINI-LOG FLOWMETER | Mar 5, 1993 | Substantially Equivalent |
| K912397 | PROFESSIONAL INDIRECT OPHTHALMOSCOPE | Oct 23, 1991 | Substantially Equivalent |
| K895953 | WRIGHT VENTILOMETER VM-1 | Feb 2, 1990 | Substantially Equivalent |
| K841430 | LASERSPEC | Dec 13, 1984 | Substantially Equivalent |
| K781313 | VISION-STIMULATOR, CAM | Jan 26, 1979 | Substantially Equivalent |