Model SP1465 Cardiac Output Computer
FDA 510(k) K861092 · Gould, Inc.
510(k) numberK861092
Submission
- Device name
- Model SP1465 Cardiac Output Computer
- Applicant
- Gould, Inc.
Oxnard, CA, US - Received
- March 24, 1986
- Decision date
- August 18, 1986
- 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 |
|---|---|---|
| K911935 | Cardiac Electrophysical Lead Selector, ModifiedDRR · Traditional | 07/22/1991SE |
| K860805 | Pressure Monitor Cath Models SP5325,SP5327,SP5337DQO · Traditional | 05/08/1986SE |
| K855145 | Model:Ta-Rose Resonant Overshoot EliminatorDRS · Traditional | 02/26/1986SE |
| K854403 | Model 2120 SpiroscreenBZG · Traditional | 01/14/1986SE |
| K851486 | Gould Disposable Transducer & Accessories-DtxDRS · Traditional | 10/17/1985SE |
| K850114 | C/Pes 9201, ECG Stress Testing SysDRT · Traditional | 02/22/1985SE |
| K850113 | C/Pes 9103, ECG Stress Testing SystemDRT · Traditional | 02/08/1985SE |
| K843555 | Cardiac Computer SP1445DXG · Traditional | 02/01/1985SE |
| K843969 | Model P23XL Physiological Pressure TransducerDXO · Traditional | 01/23/1985SE |
| K843970 | Model IM1074 End-Tidal CO2 ModuleCCK · Traditional | 10/24/1984SE |
Questions and answers
When was Model SP1465 Cardiac Output Computer cleared by the FDA?
Model SP1465 Cardiac Output Computer (K861092) received a 510(k) decision of Substantially Equivalent on August 18, 1986, 147 days after the submission was received.
What is the product code of K861092?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.