FDA.reportPublic FDA data

Lifewatch

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30277651000127138LIFEWATCH SERVICES INC1N2020-04-25O HARE INTERNATIONAL CENTER II 10255 WEST HIGGINS RD SUITE 100 Rosemont IL US 60018

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
00850725007002LifeWatch Mobile Cardiac Telemetry 3-Lead - 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Ozone/Windows/Verizon)1-800-700-3788DL-CCCSupervisors@lifewatch.com
00850725007019LifeWatch Mobile Cardiac Telemetry 3-Lead - 3 Lead Continuous ECG Monitor & Arrhythmia Detector (ES400/Windows/Verizon)1-800-700-3788DL-CCCSupervisors@lifewatch.com
00850725007026LifeWatch Mobile Cardiac Telemetry 3-Lead - 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Brigadier/Android/Verizon)1-800-700-3788DL-CCCSupervisors@lifewatch.com
00850725007033LifeWatch Mobile Cardiac Telemetry 3-Lead - 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon)1-800-700-3788DL-CCCSupervisors@lifewatch.com
00850725007040LifeWatch Mobile Cardiac Telemetry 1 Lead Patch - ECG Mini System Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon)1-800-700-3788DL-CCCSupervisors@lifewatch.com
00850725007057MicroER - Personal Electrocardiogram (ECG) Transmitter1-800-700-3788DL-CCCSupervisors@lifewatch.com
00850725007064Explorer - Card Guard Personal Electrocardiogram Transmitter1-800-700-3788DL-CCCSupervisors@lifewatch.com
00850725007071King of Hearts AF - King of Hearts Express AF Cardiac Event Recorder1-800-700-3788DL-CCCSupervisors@lifewatch.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
143411335388758K963725MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)DXH1997-09-10
143411037834986K170565LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LQYX2017-08-01
143411176867304K151269ECG Mini System Continuous ECG Monitor and Arrhythmia DetectorDSI2016-01-15
143411370057760K143359CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorDSI2015-09-11
143411040118939K110499CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTORDSI2011-04-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSI32016-01-15
QYX12017-08-01
DXH11997-09-10

PMN#

GUDID#