FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RETeval Visual Electrodiagnostic Device
K Number: K142567
·
Decision May 19, 2015
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
48
Applicant Total
8
Review Days
249
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RETeval Visual Electrodiagnostic Device
- K Number
- K142567
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lkc Technologies, Inc.
- Date Received
- September 12, 2014
- Decision Date
- May 19, 2015
- Product Code
- GWE
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWE | Stimulator, Photic, Evoked Response | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWE), ordered by most recent decision date.
E3 and Profile
FDA 510(k)
FDA Class 2
·Neurology
Vision Monitor- MonCvONE
FDA 510(k)
FDA Class 2
·Neurology
LED PHOTIC System
FDA 510(k)
FDA Class 2
·Neurology
Vision Monitor - MonpackONE
FDA 510(k)
FDA Class 2
·Neurology
Nurochek System
FDA 510(k)
FDA Class 2
·Neurology
Natus Photic Stimulator
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Lkc Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914163 | SCOPTOPIC SENSITIVITY TEST-1[SST-1] | Oct 25, 1991 | 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 |