FDA 510(k) Application Details - K243426

Device Classification Name	More FDA Info for this Device
510(K) Number	K243426
Device Name	Nurochek-Pro System
Applicant	Headsafe MFG Pty Ltd 61 Marlborough Street Suite 76 Surry Hills 2010 AU Other 510(k) Applications for this Company
Contact	Dylan Mahony Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/2024
Decision Date	03/27/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review