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Heart Sync, Inc.

FDA Regulatory Profile

Summary

Total Recalls
7 (5 Class I)
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0587-2015Class IADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeNovember 11, 2014
Z-0583-2015Class IADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStartNovember 11, 2014
Z-0585-2015Class IADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStaNovember 11, 2014
Z-0584-2015Class IADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeNovember 11, 2014
Z-0586-2015Class IADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStartNovember 11, 2014
Z-1434-2013Class IIHeart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible April 26, 2013
Z-1435-2013Class IIVermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillaApril 26, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K131550HEART SYNCDecember 6, 2013
K131494HEART SYNCSeptember 16, 2013
K120536HEART SYNC PEDIATRIC PHYSIO AED PADAugust 6, 2012
K081442HEART SYNC PEDIATRIC, MODEL PED-100September 24, 2008
K080421HEART SYNC, MODELS C-100 AND T-100February 29, 2008