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 |