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Event Medical LTD

FDA Regulatory Profile

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
7
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0230-2016Class IInspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator SysteOctober 13, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K130178INSPIRATION VENTILATOR SYSTEM 5I/7IOctober 29, 2013
K113743EVOLUTION 3E VENTILATORDecember 18, 2012
K072590INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILAJanuary 4, 2008
K051550INSPIRATION VENTILATOR SYSTEMJuly 12, 2005
K040220MEDICAL AIR COMPRESSORJune 9, 2004
K030341MODIFICATION TO INSPIRATION VENTILATOR SYSTEMJanuary 16, 2004
K021112INSPIRATION VENTILATOR SYSTEMNovember 22, 2002