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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name index-generating electroencephalograph software
510(k) Number K202621
Device Name NeuroSENSE Monitoring System, Model NS-901
Applicant
NeuroWave Systems Inc.
2490 Lee Blvd, Ste 300
Cleveland Heights,  OH  44118
Applicant Contact Tatjana Zikov
Correspondent
NeuroWave Systems Inc.
2490 Lee Blvd, Ste 300
Cleveland Heights,  OH  44118
Correspondent Contact Tatjana Zikov
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
GXT   OLT   OMC   ORT  
Date Received09/10/2020
Decision Date 08/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT02088671
Reviewed by Third Party No
Combination Product No
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