FDA 510(k) Applications for Medical Device Product Code "DTX"
(Gas Control Unit, Cardiopulmonary Bypass)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K965214 | COEUR LABORATORIES, INC. | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) | 03/28/1997 |
| K023745 | SECHRIST INDUSTRIES, INC. | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | 01/17/2003 |
| K101046 | SORIN GROUP DEUTSCHLAND GMBH | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM | 12/09/2010 |
| K181942 | Spectrum Medical Ltd | Quantum Ventilation Module | 10/18/2018 |
| K202733 | Spectrum Medical Ltd | Quantum Ventilation Module | 10/16/2020 |
| K210669 | Spectrum Medical Ltd. | Quantum Mini Ventilation Module | 05/04/2021 |
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