FDA 510(k) Application Details - K961364

Device Classification Name	Detector, Bubble, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K961364
Device Name	Detector, Bubble, Cardiopulmonary Bypass
Applicant	ROCKY MOUNTAIN RESEARCH, INC. 825 NORTH 300 WEST, SUITE 500 SALT LAKE CITY, UT 84103 US Other 510(k) Applications for this Company
Contact	ROBERT W GRIFFITHS Other 510(k) Applications for this Contact
Regulation Number	870.4205   More FDA Info for this Regulation Number
Classification Product Code	KRL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/09/1996
Decision Date	10/31/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review