510(k) K202733
- Device
- Quantum Ventilation Module
- Applicant
- Spectrum Medical Ltd
- 510(k) number
- K202733
- Product code
- DTX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-10-16
- Date received
- 2020-09-18
- Regulation
- 870.4300
- Classification name
- Gas Control Unit, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Colleen Powell
- Address
- Harrier 4, Meteor Business Park, Cheltenham Rd. E. Gloucester GB GL29QL GL29QL
FDA Registration Numbers#
- 3006073153
- 9611109
- 2020676
Source Documents#
Other 510(k) Records For Product Code DTX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210669 | Quantum Mini Ventilation Module | Spectrum Medical , Ltd. | 2021-05-04 |
| K181942 | Quantum Ventilation Module | Spectrum Medical , Ltd. | 2018-10-18 |
| K101046 | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM | Sorin Group Deutschland GmbH | 2010-12-09 |
| K023745 | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | Sechrist Industries, Inc. | 2003-01-17 |
| K965214 | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) | Coeur Laboratories, Inc. | 1997-03-28 |
| K863902 | MODIFIED SARNS MEMBRANE OXYGENATOR | 3M Health Care, Sarns | 1986-12-11 |
| K822820 | GAS-FLOW METER GFL 10 | Gambro, Inc. | 1982-10-18 |
| K792348 | STANICOR, OMNI-STAN,MOD 333B,334A GAMMA | Cordis Corp. | 1979-12-05 |
| K790546 | FLOWMETER, OPTIFLO GAS | Cobe Laboratories, Inc. | 1979-05-11 |
Legacy Summary#
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FDA Review#
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