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 IDK013354
510k NumberK013354
Device Name:GLOBALCARDIO
ClassificationRecorder, Magnetic Tape, Medical
Applicant CARDIOCOMM SOLUTIONS, INC. 3060 CEDAR HILL RD., SUITE 201 Victoria, B.c.,  CA V8t 3j5
ContactAngela Halwas
CorrespondentAngela Halwas
CARDIOCOMM SOLUTIONS, INC. 3060 CEDAR HILL RD., SUITE 201 Victoria, B.c.,  CA V8t 3j5
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-09
Decision Date2002-01-31
Summary:summary

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