FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PATTERN DISCRIMINATION PERIMETER
K Number: K874336
·
Decision Jan 12, 1988
Classifications
1
FEI Numbers
66
Registration Numbers
67
Same Product Code
40
Applicant Total
8
Review Days
82
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Basic Information
- Device Name
- PATTERN DISCRIMINATION PERIMETER
- K Number
- K874336
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1605
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Lkc Technologies, Inc.
- Date Received
- October 22, 1987
- Decision Date
- January 12, 1988
- Product Code
- HPT
- 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 |
|---|---|---|---|
| HPT | Perimeter, Automatic, Ac-Powered | FDA class 1 | Ophthalmic |
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| K913962 | ANOMALOSCOPE QUADRANT TEST-6 | Oct 23, 1991 | Substantially Equivalent |
| K875026 | ANOMALOSCOPE PLATE TEST - 5 [APT-5] | Feb 5, 1988 | Substantially Equivalent |
| K820414 | UNIVERSAL TESTING & ANALYSIS SYSTEMS | Mar 4, 1982 | Substantially Equivalent |
| K790109 | TELEMETRY, BIOMEDICAL | Mar 16, 1979 | Substantially Equivalent |
| K760199 | ELECTRORETINOGRAPH | Aug 4, 1976 | Substantially Equivalent |