Defibrillator Analyzer Variable Load

Tester, Defibrillator

BC GROUP INTERNATIONAL, INC

The following data is part of a premarket notification filed by Bc Group International, Inc with the FDA for Defibrillator Analyzer Variable Load.

Pre-market Notification Details

Device IDK153210
510k NumberK153210
Device Name:Defibrillator Analyzer Variable Load
ClassificationTester, Defibrillator
Applicant BC GROUP INTERNATIONAL, INC 3081 ELM POINT INDUSTRIAL DRIVE Saint Charles,  MO  63301
ContactMel Roche
CorrespondentMel Roche
BC GROUP INTERNATIONAL, INC 3081 ELM POINT INDUSTRIAL DRIVE Saint Charles,  MO  63301
Product CodeDRL  
CFR Regulation Number870.5325 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-05
Decision Date2015-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00863313000330 K153210 000
00863313000323 K153210 000

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