FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OSCAR COLOUR VISION TESTER
K Number: K832843
·
Decision Jan 4, 1984
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
8
Applicant Total
60
Review Days
135
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Basic Information
- Device Name
- OSCAR COLOUR VISION TESTER
- K Number
- K832843
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1170
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Keeler Instruments, Inc.
- Date Received
- August 22, 1983
- Decision Date
- January 4, 1984
- 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 |
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