FDA Product Code
FDA Product Code DTX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4300
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K210669 | Quantum Mini Ventilation Module | Spectrum Medical , Ltd. | 2021-05-04 | Traditional | PDF ↗ |
| K202733 | Quantum Ventilation Module | Spectrum Medical , Ltd. | 2020-10-16 | Special | PDF ↗ |
| K181942 | Quantum Ventilation Module | Spectrum Medical , Ltd. | 2018-10-18 | Traditional | PDF ↗ |
| K101046 | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM | Sorin Group Deutschland GmbH | 2010-12-09 | Traditional | PDF ↗ |
| K023745 | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | Sechrist Industries, Inc. | 2003-01-17 | Traditional | PDF ↗ |
| K965214 | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) | Coeur Laboratories, Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K863902 | MODIFIED SARNS MEMBRANE OXYGENATOR | 3M Health Care, Sarns | 1986-12-11 | Traditional | PDF ↗ |
| K822820 | GAS-FLOW METER GFL 10 | Gambro, Inc. | 1982-10-18 | Traditional | PDF ↗ |
| K792348 | STANICOR, OMNI-STAN,MOD 333B,334A GAMMA | Cordis Corp. | 1979-12-05 | Traditional | PDF ↗ |
| K790546 | FLOWMETER, OPTIFLO GAS | Cobe Laboratories, Inc. | 1979-05-11 | Traditional | PDF ↗ |
Product code DTX · Class II · Cardiovascular. Data: openFDA.