The following data is part of a premarket notification filed by Neurowave Systems, Inc. with the FDA for Neurosense Monitoring System, Model Ns-701.
| Device ID | K092477 |
| 510k Number | K092477 |
| Device Name: | NEUROSENSE MONITORING SYSTEM, MODEL NS-701 |
| Classification | Reduced- Montage Standard Electroencephalograph |
| Applicant | NEUROWAVE SYSTEMS, INC. 2490 LEE BLVD. SUITE 300 Cleveland Heights, OH 44118 |
| Contact | Tracie Capozzio |
| Correspondent | Tracie Capozzio NEUROWAVE SYSTEMS, INC. 2490 LEE BLVD. SUITE 300 Cleveland Heights, OH 44118 |
| Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-12 |
| Decision Date | 2010-10-29 |
| Summary: | summary |