HEARTSUITE HEMODYNAMICS 7.10
FDA 510(k) clearance K082421 · decided 2008-12-17
Clearance details
- K-number
- K082421
- Device name
- HEARTSUITE HEMODYNAMICS 7.10
- Applicant
- Emageon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-22
- Decision date
- 2008-12-17
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hartland, WI, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The Phase recall (Z-1923-2017) | Merge Healthcare, Inc. | 2017-05-02 |
| Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merg recall (Z-1778-2017) | Merge Healthcare, Inc. | 2017-04-11 |
| Merge HEMO software. recall (Z-2341-2016) | Merge Healthcare, Inc. | 2016-08-04 |
| Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN recall (Z-2347-2015) | Merge Healthcare, Inc. | 2015-08-06 |
| Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Pa recall (Z-0143-2015) | Merge Healthcare, Inc. | 2014-10-28 |