COMPUTER, THERMODILUTION CARDIAC (9520)
FDA 510(k) clearance K760192 · decided 1976-07-19
Clearance details
- K-number
- K760192
- Device name
- COMPUTER, THERMODILUTION CARDIAC (9520)
- Applicant
- Edwards Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1976-07-06
- Decision date
- 1976-07-19
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- DXG
- Device class
- 2
- Regulation number
- 870.1435
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| PulsioFlex Monitoring System with ProAQT Sensor (K192169) | Pulsion Medical Systems SE | 2020-04-30 |
| 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.