The following data is part of a premarket notification filed by Wavestate Inc with the FDA for Wavestate Neuromonitor.
| Device ID | K092625 |
| 510k Number | K092625 |
| Device Name: | WAVESTATE NEUROMONITOR |
| Classification | Burst Suppression Detection Software For Electroencephalograph |
| Applicant | WAVESTATE INC 1468 HARWELL AVE Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-08-27 |
| Decision Date | 2010-06-29 |
| Summary: | summary |