Recomed Cardiac Output Meter 236067-
FDA 510(k) K840439 · Litton Medical Electronics
510(k) numberK840439
Submission
- Device name
- Recomed Cardiac Output Meter 236067-
- Applicant
- Litton Medical Electronics
Elk Grove Village, IL, US - Received
- February 1, 1984
- Decision date
- November 20, 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K840522 | Recomed Blood-Flow Meter H236-052-02DPW · Traditional | 05/16/1985SE |
| K840899 | Servomed Arrhycomp Central Monitor SysDSI · Traditional | 11/20/1984SE |
| K840523 | Servomed Pulse Amplifier MODULE-206-DRT · Traditional | 10/29/1984SE |
| K840524 | Servomed Basic Bedside Unit SMV 110TPDRT · Traditional | 10/26/1984SE |
| K840832 | Servomed Oxcardiore Spirograph 324/111DRT · Traditional | 09/20/1984SE |
| K840209 | Servomed Medivision Scope SMV-235DXJ · Traditional | 09/20/1984SE |
| K840525 | Servomed Compact Monitor SMK 155-1/101DRT · Traditional | 06/01/1984SE |
| K840521 | Servomed Digital Display ModuleDRT · Traditional | 06/01/1984SE |
| K834600 | Recomb ECG PREAMPLIFIER/206 069 03DRT · Traditional | 06/01/1984SE |
| K833000 | I-Channel RecorderDSF · Traditional | 06/01/1984SE |
Questions and answers
When was Recomed Cardiac Output Meter 236067- cleared by the FDA?
Recomed Cardiac Output Meter 236067- (K840439) received a 510(k) decision of Substantially Equivalent on November 20, 1984, 293 days after the submission was received.
What is the product code of K840439?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.