FDA 510(k) Application Details - K132139

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K132139
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	DELTEX MEDICAL LIMITED 11440 W. BERNARDO CT. SUITE 300 SAN DIEGO, CA 92127 US Other 510(k) Applications for this Company
Contact	RONALD S WARREN 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	07/11/2013
Decision Date	10/10/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review