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Sotera Wireless, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
9
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1817-2013Class IIViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use bMay 23, 2013
Z-1818-2013Class IIViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile MonitoringMay 23, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K180472ViSi Mobile Monitoring SystemJune 19, 2018
K152341ViSi Mobile Monitoring SystemDecember 14, 2015
K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorJuly 20, 2015
K150361ViSi Mobile Monitoring SystemApril 30, 2015
K143751Visi Mobile Monitoring SystemJanuary 23, 2015
K133586VISI MOBILE MONITIORING SYSTEMDecember 18, 2013
K130709VISI MOBILE MONITORING SYSTEMOctober 7, 2013
K122036VISI MOBILE MONITORING SYSTEMAugust 15, 2012
K112478VISI MOBILE MONITORING SYSTEMMarch 22, 2012