FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLOR VISION TESTERS
K Number: K844365
·
Decision Jan 2, 1985
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
8
Applicant Total
5
Review Days
50
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Basic Information
- Device Name
- COLOR VISION TESTERS
- K Number
- K844365
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1170
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Luneau Laboratories
- Date Received
- November 13, 1984
- Decision Date
- January 2, 1985
- 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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