4 results
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37ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
FDA Recall
Terminated
·Sotera Wireless, Inc.·Product code MWI·May 23, 2013
ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
FDA Recall
Terminated
·Sotera Wireless, Inc.·Product code MWI·May 23, 2013
ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
FDA Enforcement
Class II
·Terminated·Sotera Wireless, Inc.·August 7, 2013
ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
FDA Enforcement
Class II
·Terminated·Sotera Wireless, Inc.·August 7, 2013