The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Nicolet Emg Satellite.
| Device ID | K830702 |
| 510k Number | K830702 |
| Device Name: | NICOLET EMG SATELLITE |
| Classification | Electromyograph, Diagnostic |
| Applicant | NICOLET BIOMEDICAL INSTRUMENTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-07 |
| Decision Date | 1983-07-12 |