FDA.reportPublic FDA data

CARDIOCOMMAND, INC.

Matched from indexed company URL: CARDIOCOM LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
19271971927197CARDIOCOMMAND, INC.1N2026-01-014920 WEST CYPRESS STREET SUITE 110 TAMPA FL US 33607
96805103003708031CARDIOCOMM SOLUTIONS, INC.1N2026-01-01110 Sheppard Avenue East Suite 700 Suite 700 North York Ontario CA M2N 6Y8

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00856233005134Model 7A - Patient lead wire for use with the Model 7A stimulator; white, right arm.(800) 231-6370cconley@CardioCommand.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
336351867300394P860008ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7LPA1986-12-30
336351493097844P840002STAT-PACE IILPA1986-04-30
336351950564919K905831ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATHDRF1991-03-29
336351679865599K904943TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPEBZT1991-04-26
336351072392476K903136ARZO TAPCATH ESOPHAGEAL RECORDING CATHETERDRF1991-01-18
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
336351428011889K072109STATMAP, MODEL 7200DXN2008-07-31
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
DRF21991-03-29
LPA21986-12-30
DXN12008-07-31
BZT11991-04-26

PMA#

PMN#

GUAVA II

2014-02-11

CARDIOCOMM SOLUTIONS, INC.

GUDID#