Alpha Cardiac Output Cardule #1899
FDA 510(k) K832644 · Spacelabs, Inc.
510(k) numberK832644
Submission
- Device name
- Alpha Cardiac Output Cardule #1899
- Applicant
- Spacelabs, Inc.
Mchenry, IL, US - Received
- August 5, 1983
- Decision date
- January 27, 1984
- 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 |
|---|---|---|
| K954962 | Spacelabs Medical Multigas AnalyzerCBR · Traditional | 05/31/1996SE |
| K951605 | Spacelabs Medical Casemaster Information Management SystemDSH · Traditional | 07/14/1995SE |
| K950779 | Heart Rate Variability Software OptionDPS · Traditional | 04/25/1995SE |
| K941165 | Comet Capnograph ModuleCCK · Traditional | 10/06/1994SE |
| K923788 | Space Labs Model 90560LOS · Traditional | 12/06/1993SE |
| K912742 | Esophageal Stethoscope Temperature ProbeFLL · Traditional | 04/20/1992SE |
| K913038 | Spacelab Model 90845 PCMS Multidisclosure StationDSH · Traditional | 10/04/1991SE |
| K905065 | Defibrillator Lead AdapterLDD · Traditional | 04/12/1991SE |
| K910029 | Patient Care Management System ModificationDXK · Traditional | 01/31/1991SE |
| K896903 | First Medic Model 510LDD · Traditional | 12/27/1990SE |
Questions and answers
When was Alpha Cardiac Output Cardule #1899 cleared by the FDA?
Alpha Cardiac Output Cardule #1899 (K832644) received a 510(k) decision of Substantially Equivalent on January 27, 1984, 175 days after the submission was received.
What is the product code of K832644?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.