The following data is part of a premarket notification filed by Nicolet Biomedical, Inc. with the FDA for Bravo Multi-modality System.
| Device ID | K991054 |
| 510k Number | K991054 |
| Device Name: | BRAVO MULTI-MODALITY SYSTEM |
| Classification | Full-montage Standard 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 | GWQ |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | IKN |
| Subsequent Product Code | JAF |
| Subsequent Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-30 |
| Decision Date | 1999-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830041621 | K991054 | 000 |
| 00382830032001 | K991054 | 000 |
| 00382830034579 | K991054 | 000 |
| 00382830037020 | K991054 | 000 |
| 00382830037037 | K991054 | 000 |
| 00382830037600 | K991054 | 000 |
| 00382830037617 | K991054 | 000 |
| 00382830037624 | K991054 | 000 |
| 00382830037990 | K991054 | 000 |
| 00382830031998 | K991054 | 000 |