The following data is part of a premarket notification filed by Lkc Technologies, Inc with the FDA for Reteval Visual Electrodiagnostic Device.
| Device ID | K142567 |
| 510k Number | K142567 |
| Device Name: | RETeval Visual Electrodiagnostic Device |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | LKC Technologies, Inc 2 Professional Drive, Suite 222 Gaithersburg, MD 20879 |
| Contact | Quentin Davis |
| Correspondent | Stephen J. Goldner Regulatory Affairs Associates, Inc. 40701 Woodward Avenue, Suite 102 Bloomfield Hills, MI 20879 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-12 |
| Decision Date | 2015-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857901006064 | K142567 | 000 |
| 00857901006439 | K142567 | 000 |
| 00857901006446 | K142567 | 000 |
| 00857901006453 | K142567 | 000 |
| 00857901006460 | K142567 | 000 |
| 00857901006477 | K142567 | 000 |
| 00857901006316 | K142567 | 000 |
| 20857901006006 | K142567 | 000 |
| 00857901006323 | K142567 | 000 |
| 00857901006019 | K142567 | 000 |
| 00857901006026 | K142567 | 000 |
| 00857901006033 | K142567 | 000 |
| 00857901006040 | K142567 | 000 |
| 00857901006057 | K142567 | 000 |
| 00857901006002 | K142567 | 000 |