FDA 510(k) Application Details - K070710

Device Classification Name	Transducer, Blood-Pressure, Extravascular   More FDA Info for this Device
510(K) Number	K070710
Device Name	Transducer, Blood-Pressure, Extravascular
Applicant	BIOSENSORS INTERNATIONAL-USA 20280 ACACIA ST., SUITE 300 NEWPORT BEACH, CA 92660 US Other 510(k) Applications for this Company
Contact	Sara Toyloy Other 510(k) Applications for this Contact
Regulation Number	870.2850   More FDA Info for this Regulation Number
Classification Product Code	DRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2007
Decision Date	04/19/2007
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