RETeval Visual Electrodiagnostic Device
FDA 510(k) K142567 · Lkc Technologies, Inc.
510(k) numberK142567
Submission
- Device name
- RETeval Visual Electrodiagnostic Device
- Applicant
- Lkc Technologies, Inc.
Gaithersburg, MD, US - Received
- September 12, 2014
- Decision date
- May 19, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was RETeval Visual Electrodiagnostic Device cleared by the FDA?
RETeval Visual Electrodiagnostic Device (K142567) received a 510(k) decision of Substantially Equivalent on May 19, 2015, 249 days after the submission was received.
What is the product code of K142567?
The FDA product code is GWE – Stimulator, Photic, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1890.