The following data is part of a premarket notification filed by Nicolet Biomedical, Inc. with the FDA for Nmi Software.
| Device ID | K950270 |
| 510k Number | K950270 |
| Device Name: | NMI SOFTWARE |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | NICOLET BIOMEDICAL, INC. 5225 VERONA RD. Madison, WI 53711 |
| Contact | Douglas E Pfrang |
| Correspondent | Douglas E Pfrang NICOLET BIOMEDICAL, INC. 5225 VERONA RD. Madison, WI 53711 |
| Product Code | OMB |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-23 |
| Decision Date | 1995-05-15 |