FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHROMOPS FM-100 COLOR VISION TESTER
K Number: K810700
·
Decision Apr 10, 1981
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
8
Applicant Total
3
Review Days
25
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Basic Information
- Device Name
- CHROMOPS FM-100 COLOR VISION TESTER
- K Number
- K810700
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1170
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Visidyne Corp.
- Date Received
- March 16, 1981
- Decision Date
- April 10, 1981
- 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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