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BC Group International Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0457-2016Class IIIDA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a deOctober 28, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K153210Defibrillator Analyzer Variable LoadDecember 21, 2015
K110192DEFIBRILLATOR ANALYZER - DA-2006PFebruary 8, 2011