GLOBALCARDIO

Recorder, Magnetic Tape, Medical

CARDIOCOMM SOLUTIONS, INC.

The following data is part of a premarket notification filed by Cardiocomm Solutions, Inc. with the FDA for Globalcardio.

Pre-market Notification Details

Device IDK111320
510k NumberK111320
Device Name:GLOBALCARDIO
ClassificationRecorder, Magnetic Tape, Medical
Applicant CARDIOCOMM SOLUTIONS, INC. 962 ALLEGRO LANE Apollo Beach,  FL  33572
ContactJon Ward
CorrespondentJon Ward
CARDIOCOMM SOLUTIONS, INC. 962 ALLEGRO LANE Apollo Beach,  FL  33572
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-10
Decision Date2011-10-07
Summary:summary

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