THERMODILUTION CARDIAC OUTPUT COMPUTER-
FDA 510(k) clearance K830892 · decided 1983-06-15
Clearance details
- K-number
- K830892
- Device name
- THERMODILUTION CARDIAC OUTPUT COMPUTER-
- Applicant
- American Edwards Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1983-03-21
- Decision date
- 1983-06-15
- Days to decision
- 86 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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| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GARREN GASTRIC BUBBLE (P840025/S011) | American Edwards Laboratories | 1987-03-17 |
| GARREN GASTRIC BUBBLE (P840025/S008) | American Edwards Laboratories | 1986-10-16 |
| GARREN GASTRIC BUBBLE (P840025/S006) | American Edwards Laboratories | 1986-07-25 |
| GARREN{TM}-EDWARDS GASTRIC BUBBLE (P840025/S005) | American Edwards Laboratories | 1986-05-12 |
| GARREN GASTRIC BUBBLE (P840025/S003) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S002) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S004) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S001) | American Edwards Laboratories | 1985-12-18 |