FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OSCAR COLOR VISION TESTER
K Number: K831074
·
Decision Apr 28, 1983
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
8
Applicant Total
44
Review Days
24
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OSCAR COLOR VISION TESTER
- K Number
- K831074
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1170
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Carl Zeiss, Inc.
- Date Received
- April 4, 1983
- Decision Date
- April 28, 1983
- Product Code
- HIT
- 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 |
|---|---|---|---|
| HIT | Tester, Color Vision | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIT), ordered by most recent decision date.
SLIMCATH (TM)
FDA 510(k)
FDA Class 1
·Ophthalmic
ANOMALOSCOPE PLATE TEST - 5 [APT-5]
FDA 510(k)
FDA Class 1
·Ophthalmic
H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK.
FDA 510(k)
FDA Class 1
·Ophthalmic
PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15
FDA 510(k)
FDA Class 1
·Ophthalmic
TITMUS VISION TESTER II
FDA 510(k)
FDA Class 1
·Ophthalmic
COLOR VISION TESTERS
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Carl Zeiss, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013402 | VISULAS 532S | Nov 14, 2001 | Substantially Equivalent |
| K003885 | VISULAS YAG II | Feb 22, 2001 | Substantially Equivalent |
| K993357 | IOLMASTER | Mar 20, 2000 | Substantially Equivalent |
| K983868 | OPMI TWINER SURGICAL MICROSCOPE | Jan 29, 1999 | Substantially Equivalent |
| K965139 | SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM | Apr 23, 1997 | Substantially Equivalent |
| K961380 | CPC PROBE | Mar 17, 1997 | Substantially Equivalent |
| K961171 | HUMPHREY OCT SCANNER | Jun 21, 1996 | Substantially Equivalent |
| K954167 | HUMPHREY FIELD ANALYZER (HFA II) | Nov 24, 1995 | Substantially Equivalent |
| K952894 | VISULINK 900 ARGON | Aug 14, 1995 | Substantially Equivalent |
| K950985 | ZEISS ENDOLIVE STERO ENDOSCOPE | Mar 29, 1995 | Substantially Equivalent |