DXG — Computer, Diagnostic, Pre-Programmed, Single-Function Class II
FDA Device Classification
Classification Details
- Product Code
- DXG
- Device Class
- Class II
- Regulation Number
- 870.1435
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253092 | retia medical systems | Argos Infinity (Rev. 1.0) | February 13, 2026 |
| K251275 | caretaker medical | VitalStream ART Connect; VitalStream-Hemo | September 26, 2025 |
| K232048 | icu medical | Cogent Hemodynamic Monitoring System; Cogent HMS | December 20, 2023 |
| K212529 | directed systems | Hypotension Decision Assist Model HDA-OR2 | November 23, 2021 |
| K192169 | pulsion medical systems se | PulsioFlex Monitoring System with ProAQT Sensor | April 30, 2020 |
| K193179 | edwards lifesciences | EV1000 Clinical Platform | December 17, 2019 |
| K190955 | directed systems | Hypotension Decision Assist | November 27, 2019 |
| K181372 | retia medical | Argos | December 13, 2018 |
| K172259 | pulsion medical systems se | PulsioFlex Monitoring System | January 18, 2018 |
| K163334 | lidco | LiDCOunity v2 Hemodynamic Monitor | June 5, 2017 |
| K152935 | lidco | LiDCOunity Monitor | March 17, 2016 |
| K134051 | transonic systems | TRANSONIC ELSA SYSTEM | January 29, 2015 |
| K134035 | transonic systems | TRANSONIC HCM 103 SYSTEM | September 17, 2014 |
| K140017 | transonic systems | TRANSONIC HCM 102 SYSTEM | September 16, 2014 |
| K132892 | bomed | TEBCO-W | August 1, 2014 |
| K131588 | edwards lifesciences | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY | May 22, 2014 |
| K131892 | edwards lifesciences | EV1000 CLINICAL PLATFORM | May 22, 2014 |
| K132528 | ge healthcare finland | E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES | January 16, 2014 |
| K122400 | cardiox | CARDIOX FLOW DETECTION SYSTEM | November 5, 2013 |
| K131048 | lidco | LIDCO CNAP MODULE | August 28, 2013 |