FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OCCU-TECH VISION TEST
K Number: K881971
·
Decision Nov 25, 1988
Classifications
1
FEI Numbers
106
Registration Numbers
107
Same Product Code
31
Applicant Total
1
Review Days
198
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Basic Information
- Device Name
- OCCU-TECH VISION TEST
- K Number
- K881971
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Applied Vision Concepts, Inc.
- Date Received
- May 11, 1988
- Decision Date
- November 25, 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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