FDA 510(k) Applications for Medical Device Product Code "KRL"
(Detector, Bubble, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K071231 LUNA INNOVATIONS, INC. EDAC QUANTIFIER 05/17/2007
K961364 ROCKY MOUNTAIN RESEARCH, INC. AUTOMATIC TUBING CLAMP SYSTEM (ATC) 10/31/1996
K961598 ROCKY MOUNTAIN RESEARCH, INC. ELS AUTOMATIC TUBING CLAMP SYSTEM 10/29/1996
K103469 SORIN GROUP DEUTSCHLAND GMBH STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 01/18/2011
K090698 TERUMO CARDIOVASCULAR SYSTEMS CAPIOX BUBBLE TRAP WITH X-COATING 06/08/2009


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