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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name reduced- montage standard electroencephalograph
510(k) Number K221563
Device Name Neurosteer EEG Recorder
Applicant
Neurosteer Inc.
375 South End Avenue Suite 26C
New York,  NY  10280
Applicant Contact Nathan Intrator
Correspondent
Hogan Lovells US LLP
1735 Market Street, Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number882.1400
Classification Product Code
OMC  
Subsequent Product Code
GXY  
Date Received05/31/2022
Decision Date 10/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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