510(k) K100709
- Device
- EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- 510(k) number
- K100709
- Product code
- DXG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-12-07
- Date received
- 2010-03-12
- Regulation
- 870.1435
- Classification name
- Computer, Diagnostic, Pre-programmed, Single-function
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRICIA MILBANK, JD
- Address
- One Edwards Way Irvine CA US 92614 92614
FDA Registration Numbers#
- 3010170586
- 3003617485
- 3005770916
- 3015173212
- 9710602
- 1720929
- 3007603826
- 3012528160
- 3015455735
- 3013596024
- 3013500228
- 2015691
- 3009156722
- 3013679558
- 8010042
- 9610816
- 3014541700
- 3008716327
- 3004519921
- 3005004021
- 3005580113
- 3015309643
- 3006950086
- 3010157426
- 3004415095
- 9615817
- 1651104
- 3013783488
- 3033589330
- 3016701404
- 3009077524
- 3016618143
- 3013319763
- 3007836437
- 3005877899
- 1416980
- 8020616
- 3008483389
- 3009001657
- 3016585366
- 3008132398
- 2243374
- 3004832480
- 1218950
- 3032916632
- 3008729547
- 3011353843
- 3015418961
- 3010698831
- 9681377
- 3005783425
- 3016761372
- 2648045
- 3006082230
- 1319030
- 9610105
- 3021242837
- 3012536737
- 1018233
- 9617127
- 3000126629
- 3003263092
- 2221819
- 3008403546
- 2133641
Source Documents#
Other 510(k) Records For Product Code DXG #
| 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 |
Legacy Summary#
summary
FDA Review#
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