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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 K231914
Device Name Nurochek-II System
Headsafe MFG Pty Ltd
61 Marlborough Street
Suite 76
Surry Hills,  AU 2010
Applicant Contact Adrian Cohen
2251 San Diego Avenue, Suite B-257
San Diego,  CA  92110
Correspondent Contact Erin Gontang
Regulation Number882.1400
Classification Product Code
Subsequent Product Codes
Date Received06/29/2023
Decision Date 12/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No