FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VISION-STIMULATOR, CAM
K Number: K781313
·
Decision Jan 26, 1979
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
6
Applicant Total
10
Review Days
179
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Basic Information
- Device Name
- VISION-STIMULATOR, CAM
- K Number
- K781313
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1290
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Clement Clarke, Inc.
- Date Received
- July 31, 1978
- Decision Date
- January 26, 1979
- Product Code
- HPL
- 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 |
|---|---|---|---|
| HPL | Device, Fixation, Ac-Powered, Ophthalmic | FDA class 1 | Ophthalmic |
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Other Clearances by Clement Clarke, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K914896 | FRIEDMANN ANALYSER 3 | Jan 23, 1992 | 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 |