FDA.reportPublic FDA data

CARDIOCOMM SOLUTIONS, INC.

Matched from indexed company URL: CardioComm Solutions, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96805103003708031CARDIOCOMM SOLUTIONS, INC.1N2026-01-01110 Sheppard Avenue East Suite 700 Suite 700 North York Ontario CA M2N 6Y8

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
483771895788839K181310HeartCheck Cardi Beat ECG Monitor with GEMS MobileDXH2019-02-22
483771885463165K122632GUAVA IIDPS2014-02-11
483772024243448K121009HEARTCHECK ECG PEN WITH GEMS HOMEDPS2012-05-17
483771871971862K111320GLOBALCARDIODSH2011-10-07
483771323797951K111159HEARTCHECK PEN HANDHELD ECG WITH GEMS HOMEDPS2011-12-22
483771524221227K080933HANDHELD ECG MONITOR, MODEL MD100DPS2008-09-26
483771603247433K033037MODIFICATION TO GLOBALCARDIODSH2003-10-31
483771026201043K022297GLOBAL ECG MANAGEMENT SYSTEM (GEMS)DSH2002-09-27
483771914541262K020366GLOBAL ECG MANAGEMENT SYSTEM (GEMS)DPS2002-04-30
483771331638036K013354GLOBALCARDIODSH2002-01-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DPS102014-02-11
DSH82011-10-07
DXH22019-02-22

PMN#

GUAVA II

2014-02-11

CARDIOCOMM SOLUTIONS, INC.

GUDID#