FDA 510(k) Applications for Medical Device Product Code "DRY"
(Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K972962 | 3M COMPANY | 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 | 11/06/1997 |
| K973472 | 3M HEALTH CARE | 3M CDI H/S CUVETTES WITH HEPARON TREATMENT | 12/08/1997 |
| K980732 | 3M HEALTH CARE | 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT | 05/15/1998 |
| K001388 | DIDECO | DATA MASTER PERFUSION MONITORING SYSTEM | 07/28/2000 |
| K955379 | INTERNATIONAL BIOPHYSICS CORP. | IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) | 05/14/1996 |
| K955380 | INTERNATIONAL BIOPHYSICS CORP. | IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) | 05/14/1996 |
| K202154 | LivaNova Deutschland GmbH | B-Capta | 04/01/2021 |
| K090147 | MAQUET CARDIOPULMONARY AG | BLOOD MONITORING UNIT, MODEL BMU 40 | 04/22/2009 |
| K012743 | MEDTRONIC PERFUSION SYSTEMS | TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T | 09/14/2001 |
| K133157 | MEDTRONIC, INC. | TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 | 10/23/2014 |
| K103168 | SORIN GROUP DEUTSCHLAND GMBH | B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) | 01/06/2011 |
| K071725 | SPECTRUM MEDICAL LTD | M2 MONITOR | 07/11/2007 |
| K072131 | SPECTRUM MEDICAL LTD | M3 MONITOR | 08/17/2007 |
| K091908 | SPECTRUM MEDICAL LTD | M3 MONITOR | 07/10/2009 |
| K173591 | Spectrum Medical Ltd | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | 03/28/2018 |
| K163657 | Spectrum Medical Ltd | Quantum Workstation | 01/18/2017 |
| K202557 | Spectrum Medical Ltd | Quantum Workstation 12 Elite | 10/02/2020 |
| K181923 | Spectrum Medical Ltd | Quantum Workstation 12.1 | 08/17/2018 |
| K110957 | SPECTRUM MEDICAL, LLP | M4 MONITOR | 05/31/2011 |
| K062468 | SPECTRUM MEDICAL, LLP | SPECTRUM M2 MONITOR | 09/13/2006 |
| K123039 | TERUMO CARDIOVASCULAR SYSTEMS CORP. | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | 11/20/2012 |
| K133658 | TERUMO CARDIOVASCULAR SYSTEMS CORP. | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | 07/25/2014 |
| K182110 | Terumo Cardiovascular Systems Corporation | CDI Blood Parameter Monitoring System 550 | 11/02/2018 |
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