The following data is part of a premarket notification filed by Neurowave Systems Inc. with the FDA for Neurosense Monitoring System, Model Ns-901.
| Device ID | K202621 |
| 510k Number | K202621 |
| Device Name: | NeuroSENSE Monitoring System, Model NS-901 |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | NeuroWave Systems Inc. 2490 Lee Blvd, Ste 300 Cleveland Heights, OH 44118 |
| Contact | Tatjana Zikov |
| Correspondent | Tatjana Zikov NeuroWave Systems Inc. 2490 Lee Blvd, Ste 300 Cleveland Heights, OH 44118 |
| Product Code | OLW |
| Subsequent Product Code | GXT |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMC |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-10 |
| Decision Date | 2021-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B746EK9011 | K202621 | 000 |