FDA 510(k) Application Details - K232023

Device Classification Name	Device, Sensing, Optical Contour   More FDA Info for this Device
510(K) Number	K232023
Device Name	Device, Sensing, Optical Contour
Applicant	Momentum Health Inc. 2727 Rue St-Patrick, Apt 109 Montreal H3K0A8 CA Other 510(k) Applications for this Company
Contact	Evan Dimentberg Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LDK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2023
Decision Date	10/04/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review