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510(k) K181658

Device
MobileECG 2 BT
Applicant
Memtec Corporation
510(k) number
K181658
Product code
DSI  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-26
Date received
2018-06-25
Regulation
870.1025
Classification name
Detector And Alarm, Arrhythmia
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dennis Garboski
Address
68 Stiles Rd. Unit D Salem NH US 03079 03079

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DSI  #

510(k), Device, Applicant table
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K192732BodyGuardian Remote Monitoring SystemPreventice Technologies, Inc.2020-03-26
K190574Patient Assistant Model PA97000Medtronic, Inc.2019-09-24
K182532Liba3 SystemNational Cardiac, Inc.2019-05-15
K173969Medicalgorithmics Unified Cardiac Rehabilitation SystemMedicalgorithmics S.A.2018-07-11
K173170Epicardia AnywhereMedicomp, Inc.2018-01-10
K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC2016-07-22
K153477EMMa Electronic Monitoring ManagementVitasystems GmbH2016-05-25
K152701Matrix Mini ECG MonitorGlobal Instrumentation, LLC2016-04-22
K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation2016-04-08