FDA 510(k) Application Details - K193321

Device Classification Name	Monitor, Pressure, Intracompartmental   More FDA Info for this Device
510(K) Number	K193321
Device Name	Monitor, Pressure, Intracompartmental
Applicant	MY01, Inc. 85 Rue Saint-Paul Ouest, Suite 200 Montreal H2Y 3V4 CA Other 510(k) Applications for this Company
Contact	Charles Allan 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	12/02/2019
Decision Date	07/30/2020
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