FDA 510(k) Application Details - K192966

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K192966
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	Laser Associated Sciences, Inc. 5171 California Ave., Suite 150 Irvine, CA 92617 US Other 510(k) Applications for this Company
Contact	Sean White Other 510(k) Applications for this Contact
Regulation Number	870.2100   More FDA Info for this Regulation Number
Classification Product Code	DPW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2019
Decision Date	01/10/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review