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 Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/10/2020 |
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
|
|
|