The following data is part of a premarket notification filed by Lkc Technologies, Inc. with the FDA for Electroretinograph.
Device ID | K760199 |
510k Number | K760199 |
Device Name: | ELECTRORETINOGRAPH |
Classification | Electrode, Corneal |
Applicant | LKC TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HLZ |
CFR Regulation Number | 886.1220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-07 |
Decision Date | 1976-08-04 |