FDA 510(k) K142567, RETeval Visual Electrodiagnostic Device, by Lkc Technologies, Inc.
FDA 510(k) K142567, RETeval Visual Electrodiagnostic Device, by Lkc Technologies, Inc.
Device Classification Name: Stimulator, Photic, Evoked Response
510(k) Number: K142567
Device Name: RETeval Visual Electrodiagnostic Device
Applicant: Lkc Technologies, Inc.
Regulation Number: 882.1890
Classification Product Code: GWE
Date Received: 09/12/2014
Decision Date: 05/19/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
510k Review Panel: Neurology
Total number of pages: 2,960
Fully redacted pages: 2,040
Content pages: 920
Couldn't load pickup availability
PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.
View full details