The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Multi-signal Auditory Stimulator Sm700.
| Device ID | K830579 |
| 510k Number | K830579 |
| Device Name: | MULTI-SIGNAL AUDITORY STIMULATOR SM700 |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | NICOLET BIOMEDICAL INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-23 |
| Decision Date | 1983-03-08 |