FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCOPTOPIC SENSITIVITY TEST-1[SST-1]
K Number: K914163
·
Decision Oct 25, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
17
Applicant Total
8
Review Days
38
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Basic Information
- Device Name
- SCOPTOPIC SENSITIVITY TEST-1[SST-1]
- K Number
- K914163
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1630
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lkc Technologies, Inc.
- Date Received
- September 17, 1991
- Decision Date
- October 25, 1991
- Product Code
- HLX
- 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 |
|---|---|---|---|
| HLX | Photostimulator, Ac-Powered | FDA class 2 | Ophthalmic |
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|---|---|---|---|
| K142567 | RETeval Visual Electrodiagnostic Device | May 19, 2015 | Substantially Equivalent |
| K913962 | ANOMALOSCOPE QUADRANT TEST-6 | Oct 23, 1991 | Substantially Equivalent |
| K875026 | ANOMALOSCOPE PLATE TEST - 5 [APT-5] | Feb 5, 1988 | Substantially Equivalent |
| K874336 | PATTERN DISCRIMINATION PERIMETER | Jan 12, 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 |