DEFIBRILLATOR ANALYZER - DA-2006P

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 - Da-2006p.

Pre-market Notification Details

Device IDK110192
510k NumberK110192
Device Name:DEFIBRILLATOR ANALYZER - DA-2006P
ClassificationTester, Defibrillator
Applicant BC GROUP INTERNATIONAL, INC 2913 209TH LANE NW Oak Grove,  MN  55011
ContactJack Slovick
CorrespondentPaula Wilkerson
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeDRL  
CFR Regulation Number870.5325 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-01-24
Decision Date2011-02-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00863313000354 K110192 000
00863313000347 K110192 000
00863313000316 K110192 000
00863313000309 K110192 000

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