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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
510(k) Number K243426
Device Name Nurochek-Pro System
Applicant
Headsafe MFG Pty Ltd
61 Marlborough Street
Suite 76
Surry Hills,  AU 2010
Applicant Contact Dylan Mahony
Correspondent
RQM+
2790 Mosside Blvd. Suite 800.
Monroeville,  PA  15146
Correspondent Contact Erin Gontang
Regulation Number882.1450
Classification Product Code
PIW  
Subsequent Product Code
OMC  
Date Received11/04/2024
Decision Date 03/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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