FDA 510(k) Application Details - K182333

Device Classification Name	System, Optical Position/Movement Recording   More FDA Info for this Device
510(K) Number	K182333
Device Name	System, Optical Position/Movement Recording
Applicant	Reflexion Health, Inc. 225 Broadway Ste. 300 San Diego, CA 92101 US Other 510(k) Applications for this Company
Contact	Walter Cordiglia Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LXJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2018
Decision Date	04/09/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review