FLOWMETER, OPTIFLO GAS
FDA 510(k) clearance K790546 · decided 1979-05-11
Clearance details
- K-number
- K790546
- Device name
- FLOWMETER, OPTIFLO GAS
- Applicant
- Cobe Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-03-20
- Decision date
- 1979-05-11
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- DTX
- Device class
- 2
- Regulation number
- 870.4300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Quantum Mini Ventilation Module (K210669) | Spectrum Medical , Ltd. | 2021-05-04 |
| Quantum Ventilation Module (K202733) | Spectrum Medical , Ltd. | 2020-10-16 |
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| STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM (K101046) | Sorin Group Deutschland GmbH | 2010-12-09 |
| SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G (K023745) | Sechrist Industries, Inc. | 2003-01-17 |
| COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) (K965214) | Coeur Laboratories, Inc. | 1997-03-28 |
| MODIFIED SARNS MEMBRANE OXYGENATOR (K863902) | 3M Health Care, Sarns | 1986-12-11 |
| GAS-FLOW METER GFL 10 (K822820) | Gambro, Inc. | 1982-10-18 |
| STANICOR, OMNI-STAN,MOD 333B,334A GAMMA (K792348) | Cordis Corp. | 1979-12-05 |
Recalls involving this device
No recalls on record reference this clearance.