System 5000
FDA 510(k) K833756 · Medical Graphics Corp.
510(k) numberK833756
Submission
- Device name
- System 5000
- Applicant
- Medical Graphics Corp.
Mchenry, IL, US - Received
- October 26, 1983
- Decision date
- April 24, 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 |
|---|---|---|
| K242809 | Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional | 10/17/2024SE |
| K181912 | Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional | 04/12/2019SE |
| K152585 | Resmon PRO FULLPNV · Traditional | 06/24/2016SE |
| K070858 | Express SeriesBZL · Special | 04/16/2007SE |
| K061731 | Medgraphics Ultima SystemBZL · Special | 09/06/2006SE |
| K955432 | CPX, CCM, Cath with 15% CO2BZM · Traditional | 07/01/1996SE |
| K943259 | 1085 Ultimate E PlethysmographCCM · Traditional | 04/10/1995SE |
| K923209 | Medgraphics Exercise ConsultBZM · Traditional | 03/11/1993SE |
| K912906 | Medgraphics Pf/DxBZL · Traditional | 02/04/1992SE |
| K896345 | Exercise Evaluation System 2010BZM · Traditional | 01/20/1990SE |
Questions and answers
When was System 5000 cleared by the FDA?
System 5000 (K833756) received a 510(k) decision of Substantially Equivalent on April 24, 1984, 181 days after the submission was received.
What is the product code of K833756?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.