BC Group International Inc

FDA Regulatory Profile

BC Group International Inc appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0457-2016, Class III) was initiated on October 28, 2015. Its most recent 510(k) clearance was granted on December 21, 2015.

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