Flowmeter, Optiflo Gas
FDA 510(k) K790546 · Cobe Laboratories, Inc.
510(k) numberK790546
Submission
- Device name
- Flowmeter, Optiflo Gas
- Applicant
- Cobe Laboratories, Inc.
Mchenry, IL, US - Received
- March 20, 1979
- Decision date
- May 11, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTX – Gas Control Unit, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K101046 | Stockert S5 System and Gas Blender and Sorin C5 SystemDTX · Traditional | Sorin Group Deutschland GmbH | 12/09/2010SE |
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| K965214 | Coeur Front Load Injector Retrofit Kit (C859-0002)DTX · Traditional | Coeur Laboratories, Inc. | 03/28/1997SE |
| K863902 | Modified Sarns Membrane OxygenatorDTX · Traditional | 3M Health Care, Sarns | 12/11/1986SE |
| K822820 | Gas-Flow Meter GFL 10DTX · Traditional | Gambro, Inc. | 10/18/1982SE |
| K792348 | Stanicor, Omni-Stan,Mod 333B,334A GammaDTX · Traditional | Cordis Corp. | 12/05/1979SE |
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| K904566 | New Cobe Centrysystem(Tm) 100 HG DialyzerFJI · Traditional | 12/12/1990SE |
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Questions and answers
When was Flowmeter, Optiflo Gas cleared by the FDA?
Flowmeter, Optiflo Gas (K790546) received a 510(k) decision of Substantially Equivalent on May 11, 1979, 52 days after the submission was received.
What is the product code of K790546?
The FDA product code is DTX – Gas Control Unit, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4300.