FDA 510(k) Application Details - K242997

Device Classification Name	Monitor, Pressure, Intracompartmental   More FDA Info for this Device
510(K) Number	K242997
Device Name	Monitor, Pressure, Intracompartmental
Applicant	MY01 Inc. 400 De Maisonneuve Boulevard West, Suite 700 Montreal H3A 1L4 CA Other 510(k) Applications for this Company
Contact	Olivier Bataille Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2024
Decision Date	03/13/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review