The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Nicolet Viking.
Device ID | K842956 |
510k Number | K842956 |
Device Name: | NICOLET VIKING |
Classification | Electromyograph, Diagnostic |
Applicant | NICOLET BIOMEDICAL INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IKN |
CFR Regulation Number | 890.1375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-27 |
Decision Date | 1984-08-03 |