Product code DXG
- Device name
- Computer, Diagnostic, Pre-Programmed, Single-Function
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1435
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253092 | Argos Infinity (Rev. 1.0) | Retia Medical Systems, Inc. | 2026-02-13 |
| K251275 | VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical | 2025-09-26 |
| K232048 | Cogent™ Hemodynamic Monitoring System; Cogent™ HMS | Icu Medical | 2023-12-20 |
| K212529 | Hypotension Decision Assist Model HDA-OR2 | Directed Systems, Ltd. | 2021-11-23 |
| K192169 | PulsioFlex Monitoring System with ProAQT Sensor | Pulsion Medical Systems SE | 2020-04-30 |
| K193179 | EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2019-12-17 |
| K190955 | Hypotension Decision Assist | Directed Systems, Ltd. | 2019-11-27 |
| K181372 | Argos | Retia Medical, LLC | 2018-12-13 |
| K172259 | PulsioFlex Monitoring System | Pulsion Medical Systems SE | 2018-01-18 |
| K163334 | LiDCOunity v2 Hemodynamic Monitor | Lidco, Ltd. | 2017-06-05 |
| K152935 | LiDCOunity Monitor | Lidco, Ltd. | 2016-03-17 |
| K134051 | TRANSONIC ELSA SYSTEM | Transonic Systems, Inc. | 2015-01-29 |
| K134035 | TRANSONIC HCM 103 SYSTEM | Transonic Systems, Inc. | 2014-09-17 |
| K140017 | TRANSONIC HCM 102 SYSTEM | Transonic Systems, Inc. | 2014-09-16 |
| K132892 | TEBCO-W | Bomed, Inc. | 2014-08-01 |
| K131588 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR | Edwards Lifesciences, LLC | 2014-05-22 |
| K131892 | EV1000 CLINICAL PLATFORM | Edwards Lifesciences, LLC | 2014-05-22 |
| K132528 | E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES | GE Healthcare Finland Oy | 2014-01-16 |
| K122400 | CARDIOX FLOW DETECTION SYSTEM | Cardiox Corp. | 2013-11-05 |
| K131048 | LIDCO CNAP MODULE | Lidco, Ltd. | 2013-08-28 |
| K122247 | LIDCORAPID V2 MONITOR | Lidco, Ltd. | 2013-03-20 |
| K113821 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM | Transonic Systems, Inc. | 2012-09-07 |
| K122121 | PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE | Pulsion Medical Systems SE | 2012-08-02 |
| K112448 | PULSIOFLEX | Pulsion Medical Systems, Inc. | 2011-09-22 |
| K110597 | EV1000 CLINICAL PLATFORM | Edwards Lifesciences | 2011-06-14 |
| K103094 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR | Edwards Lifesciences, LLC | 2011-05-17 |
| K100709 | EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M | Edwards Lifesciences, LLC | 2010-12-07 |
| K101487 | CHEETAH NICOM SYSTEM | Cheetah Medical, Inc. | 2010-07-02 |
| K091786 | PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48) | Pulsion Medical Systems AG | 2010-06-18 |
| K092219 | NAVIGATOR CLINICAL GUIDENCE SYSTEM | Applied Physiology Pty , Ltd. | 2010-05-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 17290020154009 | BB-613P Chest-Monitor 40-Unit Multipack | BIOBEAT TECHNOLOGIES LTD | 2025-03-05 |
| 47290013030045 | Starling | CHEETAH MEDICAL (ISRAEL) LTD | 2023-12-12 |
| 27290013030041 | Starling | CHEETAH MEDICAL (ISRAEL) LTD | 2023-12-12 |
| 17290013030044 | Starling | CHEETAH MEDICAL (ISRAEL) LTD | 2023-12-12 |
| 00195278522313 | CARESCAPE Canvas Smart Display | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278524089 | NA | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278523365 | CARESCAPE Canvas D19 | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278522320 | CARESCAPE Canvas 1000 | GE Healthcare Finland Oy | 2023-04-19 |
| 18904269452886 | STAR 65 | SKANRAY TECHNOLOGIES LIMITED | 2019-01-21 |
| 10841522107771 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-03-10 |
| 10841522107788 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-03-10 |
| 10841522103841 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-03-07 |
| 20884838072248 | Spirometry Sensor | Philips Medizin Systeme Böblingen GmbH | 2017-01-20 |
| 10841522108792 | Spacelabs | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-11-15 |
| 10841522108785 | Spacelabs | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-11-15 |
| 10841522108778 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-11-15 |
| 10841522106415 | Ultraview SL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-07 |
| 10841522106439 | Ultraview SL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-07 |
| 10841522106422 | Ultraview SL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-07 |
| 20884838028726 | Genius 2 | Philips Medical Systems Hsg | 2016-10-05 |
| 00690103163384 | PRESEP | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103181418 | VIGILEO | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103187267 | VIGILEO | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103190106 | EV1000 | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103193213 | EV1000 | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103193367 | CLEARSIGHT | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103193374 | EV1000 | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103193473 | EV1000 | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103193541 | EV1000 | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103193558 | EV1000 | Edwards Lifesciences LLC | 2016-09-03 |