Cardiacindex Computer Model SP 1435
FDA 510(k) K802476 · Gould, Inc.
510(k) numberK802476
Submission
- Device name
- Cardiacindex Computer Model SP 1435
- Applicant
- Gould, Inc.
Walker, MI, US - Received
- October 9, 1980
- Decision date
- November 19, 1980
- 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
Other 510(k)s with product code DXG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253092 | Argos Infinity (Rev. 1.0)DXG · Traditional | Retia Medical Systems, Inc. | 02/13/2026SE |
| K251275 | VitalStream ART Connect; VitalStream-HemoDXG · Traditional | Caretaker Medical | 09/26/2025SE |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional | Icu Medical | 12/20/2023SE |
| K212529 | Hypotension Decision Assist Model HDA-OR2DXG · Special | Directed Systems, Ltd. | 11/23/2021SE |
| K192169 | PulsioFlex Monitoring System with ProAQT SensorDXG · Traditional | Pulsion Medical Systems SE | 04/30/2020SE |
| K193179 | EV1000 Clinical PlatformDXG · Special | Edwards Lifesciences, LLC | 12/17/2019SE |
| K190955 | Hypotension Decision AssistDXG · Traditional | Directed Systems, Ltd. | 11/27/2019SE |
| K181372 | ArgosDXG · Traditional | Retia Medical, LLC | 12/13/2018SE |
| K172259 | PulsioFlex Monitoring SystemDXG · Traditional | Pulsion Medical Systems SE | 01/18/2018SE |
| 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 |
| K861092 | Model SP1465 Cardiac Output ComputerDXG · Traditional | 08/18/1986SE |
| 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 |
Questions and answers
When was Cardiacindex Computer Model SP 1435 cleared by the FDA?
Cardiacindex Computer Model SP 1435 (K802476) received a 510(k) decision of Substantially Equivalent on November 19, 1980, 41 days after the submission was received.
What is the product code of K802476?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.