FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)
K Number: K014044
·
Decision Mar 4, 2002
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
7
Applicant Total
3
Review Days
87
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Basic Information
- Device Name
- MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)
- K Number
- K014044
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1330
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Notal Vision, Inc.
- Date Received
- December 7, 2001
- Decision Date
- March 4, 2002
- Product Code
- HOQ
- 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 |
|---|---|---|---|
| HOQ | Grid, Amsler | FDA class 1 | Ophthalmic |
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