MCKESSON CARDIOLOGY HEMO
FDA 510(k) clearance K131497 · decided 2013-12-05
Clearance details
- K-number
- K131497
- Device name
- MCKESSON CARDIOLOGY HEMO
- Applicant
- Mckesson Israel , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-05-24
- Decision date
- 2013-12-05
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- MWI
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Change Healthcare Cardiology Hemo Software recall (Z-2071-2025) | CHANGE HEALTHCARE CANADA COMPANY | 2025-07-02 |
| McKesson Cardiology Hemo software recall (Z-0957-2025) | A L I Technologies Ltd | 2025-01-16 |
| Change Healthcare Cardiology Hemo software recall (Z-0958-2025) | A L I Technologies Ltd | 2025-01-16 |
| Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1 recall (Z-0126-2025) | CHANGE HEALTHCARE CANADA COMPANY | 2024-10-17 |
| McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0. recall (Z-0128-2025) | CHANGE HEALTHCARE CANADA COMPANY | 2024-10-17 |
| McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological recall (Z-0093-2015) | Mckesson Information Solutions LLC | 2014-10-20 |
| McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clin recall (Z-0042-2015) | Mckesson Information Solutions LLC | 2014-10-08 |