MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
FDA 510(k) clearance K082308 · decided 2008-12-09
Clearance details
- K-number
- K082308
- Device name
- MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-08-13
- Decision date
- 2008-12-09
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- DXG
- Device class
- 2
- Regulation number
- 870.1435
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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| EV1000 Clinical Platform (K193179) | Edwards Lifesciences, LLC | 2019-12-17 |
| Hypotension Decision Assist (K190955) | Directed Systems, Ltd. | 2019-11-27 |
| Argos (K181372) | Retia Medical, LLC | 2018-12-13 |
| PulsioFlex Monitoring System (K172259) | Pulsion Medical Systems SE | 2018-01-18 |
| LiDCOunity v2 Hemodynamic Monitor (K163334) | Lidco, Ltd. | 2017-06-05 |
| LiDCOunity Monitor (K152935) | Lidco, Ltd. | 2016-03-17 |
| TRANSONIC ELSA SYSTEM (K134051) | Transonic Systems, Inc. | 2015-01-29 |
Recalls involving this device
No recalls on record reference this clearance.