Cardiac Output Computer, Mdel 9520A
FDA 510(k) K790047 · Edwards Laboratories
510(k) numberK790047
Submission
- Device name
- Cardiac Output Computer, Mdel 9520A
- Applicant
- Edwards Laboratories
Mchenry, IL, US - Received
- January 5, 1979
- Decision date
- February 26, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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| K181372 | ArgosDXG · Traditional | Retia Medical, LLC | 12/13/2018SE |
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| K163334 | LiDCOunity v2 Hemodynamic MonitorDXG · Traditional | Lidco, Ltd. | 06/05/2017SE |
More from Lidco, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K801552 | Mod. 9542 Flow-Thru Inject. Temp. SensorKRB · Traditional | 07/28/1980SE |
| K800655 | Model 100 SpectraviewDQC · Traditional | 04/16/1980SE |
| K792441 | Carpentier-Edwards Flex. AnnuloplastyKRH · Traditional | 03/17/1980PT |
| K792034 | Integral Disposable Holder CarpentierDTJ · Traditional | 12/07/1979SE |
| K790022 | Disposable Holder for BioprosthesisDTJ · Traditional | 01/15/1979SE |
| K781535 | Ac Adapter:Models 9525,9526,9527DXG · Traditional | 09/15/1978SE |
| K771663 | Probe & CatheterKRB · Traditional | 09/20/1977SE |
| K771046 | Vena Cava Umbrella Filter, Model 7321DTK · Traditional | 06/22/1977SE |
| K760151 | Applicator,Angiography (7310MOBIN-UDDIN)DTK · Traditional | 08/26/1976SE |
| K760192 | Computer, Thermodilution Cardiac (9520)DXG · Traditional | 07/19/1976SE |
Questions and answers
When was Cardiac Output Computer, Mdel 9520A cleared by the FDA?
Cardiac Output Computer, Mdel 9520A (K790047) received a 510(k) decision of Substantially Equivalent on February 26, 1979, 52 days after the submission was received.
What is the product code of K790047?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.