The following data is part of a premarket notification filed by Lkc Technologies, Inc. with the FDA for Universal Testing & Analysis Systems.
Device ID | K820414 |
510k Number | K820414 |
Device Name: | UNIVERSAL TESTING & ANALYSIS SYSTEMS |
Classification | Stimulator, Electrical, Evoked Response |
Applicant | LKC TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GWF |
CFR Regulation Number | 882.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-12 |
Decision Date | 1982-03-04 |