FDA 510(k) Application Details - K162042

Device Classification Name	Pump, Infusion, Analytical Sampling   More FDA Info for this Device
510(K) Number	K162042
Device Name	Pump, Infusion, Analytical Sampling
Applicant	OPTISCAN BIOMEDICAL CORP. 24590 CLAWITER ROAD HAYWARD, CA 94545 US Other 510(k) Applications for this Company
Contact	DON WEBBER Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	LZF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2016
Decision Date	10/16/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review