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FDA 510(k) Applications Submitted by CARDIOCOMM SOLUTIONS, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K020366
02/04/2002
GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
CARDIOCOMM SOLUTIONS, INC.
K022297
07/16/2002
GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
CARDIOCOMM SOLUTIONS, INC.
K013354
10/09/2001
GLOBALCARDIO
CARDIOCOMM SOLUTIONS, INC.
K033037
09/29/2003
MODIFICATION TO GLOBALCARDIO
CARDIOCOMM SOLUTIONS, INC.
K181310
05/17/2018
HeartCheck Cardi Beat ECG Monitor with GEMS Mobile
CardioComm Solutions, Inc.
K111320
05/10/2011
GLOBALCARDIO
CARDIOCOMM SOLUTIONS, INC.
K122632
08/29/2012
GUAVA II
CARDIOCOMM SOLUTIONS, INC.
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