DRY — Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Class 2

Medical Specialty

Review Panel

Submission Type

FDA Authorisations (47)

Device Name	Manufacturer	K-Number	Decision Date
CDI OneView Monitoring System	Terumo Cardiovascular Systems Corporation	K234065	2024-04-25
B-Capta	Livanova Deutschland, GmbH	K202154	2021-04-01
Quantum Workstation 12 Elite	Spectrum Medical , Ltd.	K202557	2020-10-02
CDI Blood Parameter Monitoring System 550	Terumo Cardiovascular Systems Corporation	K182110	2018-11-02
Quantum Workstation 12.1	Spectrum Medical , Ltd.	K181923	2018-08-17
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas	Spectrum Medical , Ltd.	K173591	2018-03-28
Quantum Workstation	Spectrum Medical , Ltd.	K163657	2017-01-18
TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6	Medtronic, Inc.	K133157	2014-10-23
CDI BLOOD PARAMETER MONITORING SYSTEM 500	Terumo Cardiovascular Systems Corp.	K133658	2014-07-25
CDI BLOOD PARAMETER MONITORING SYSTEM 500	Terumo Cardiovascular Systems Corp.	K123039	2012-11-20
M4 MONITOR	Spectrum Medical, Llp	K110957	2011-05-31
B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)	Sorin Group Deutschland GmbH	K103168	2011-01-06
M3 MONITOR	Spectrum Medical , Ltd.	K091908	2009-07-10
BLOOD MONITORING UNIT, MODEL BMU 40	Maquet Cardiopulmonary, AG	K090147	2009-04-22
M3 MONITOR	Spectrum Medical , Ltd.	K072131	2007-08-17
M2 MONITOR	Spectrum Medical , Ltd.	K071725	2007-07-11
SPECTRUM M2 MONITOR	Spectrum Medical, Llp	K062468	2006-09-13
TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T	Medtronic Perfusion Systems	K012743	2001-09-14
DATA MASTER PERFUSION MONITORING SYSTEM	Dideco	K001388	2000-07-28
3M CDI QUICK-CELLS WITH HEPARIN TREATMENT	3M Healthcare	K980732	1998-05-15

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