2 results
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39ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors.
FDA Recall
Terminated
·Preventice Services, LLC·Product code DSI·August 6, 2019
BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors.
FDA Enforcement
Class II
·Terminated·Preventice Services, LLC·July 8, 2020