FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPTEC 1000 DMV VISION TESTER MODIFY
K Number: K875237
·
Decision Mar 17, 1988
Classifications
1
FEI Numbers
109
Registration Numbers
110
Same Product Code
31
Applicant Total
5
Review Days
86
Basic Information
- Device Name
- OPTEC 1000 DMV VISION TESTER MODIFY
- K Number
- K875237
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- STEREO OPTICAL CO., INC.
- Date Received
- December 22, 1987
- Decision Date
- March 17, 1988
- Product Code
- HOX
- 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 |
|---|---|---|---|
| HOX | Chart, Visual Acuity | FDA class 1 | Ophthalmic |
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