The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Compact Auditory.
| Device ID | K842612 |
| 510k Number | K842612 |
| Device Name: | COMPACT AUDITORY |
| 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 | 1984-07-05 |
| Decision Date | 1984-07-20 |