Mckesson Israel , Ltd.
Medical device manufacturer in Tel Aviv, Isra.
5510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K151850 | McKesson CardiologyLLZ · Traditional | 08/11/2015SE |
| K133534 | Mckesson Cardiology ECG MobileDQK · Traditional | 04/18/2014SE |
| K131497 | Mckesson Cardiology HemoMWI · Traditional | 12/05/2013SE |
| K113515 | Horizon Cardiology ECG ManagementDQK · Traditional | 03/16/2012SE |
| K112720 | Mckesson Horizon CardiologyLLZ · Traditional | 01/30/2012SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2968-2018 Class II | McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring…Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM)… | 03/12/2018Terminated |
| Z-0910-2015 Class II | McKesson Cardiology ECG Management It is a software application designed to import…An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management… | 12/19/2014Terminated |