MODIFICATION TO 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 Modification To Globalcardio.

Pre-market Notification Details

Device IDK033037
510k NumberK033037
Device Name:MODIFICATION TO GLOBALCARDIO
ClassificationRecorder, Magnetic Tape, Medical
Applicant CARDIOCOMM SOLUTIONS, INC. 3060 CEDAR HILL RD., SUITE 201 Victoria, B.c.,  CA V8t 3j5
ContactJanet Wainman
CorrespondentJanet Wainman
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 Received2003-09-29
Decision Date2003-10-31
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.