FDA 510(k) Application Details - K040654

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K040654
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	OPTICAL SENSORS, INC. 800 LENANGER LN. STOUGHTON, WI 53589 US Other 510(k) Applications for this Company
Contact	Gary Syring 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	03/12/2004
Decision Date	06/04/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review