FDA 510(k) Application Details - K183485

Device Classification Name	Device, Sensing, Optical Contour   More FDA Info for this Device
510(K) Number	K183485
Device Name	Device, Sensing, Optical Contour
Applicant	Cryos Technologies Inc. 385 rue Salaberry Joliette J6E 4G4 CA Other 510(k) Applications for this Company
Contact	John A. Stimpson 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	12/17/2018
Decision Date	08/28/2019
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