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MXC — Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) Class II

FDA Device Classification

Classification Details

Product Code
MXC
Device Class
Class II
Regulation Number
870.2800
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K230286abbott medicalAssert-IQ™ Insertable Cardiac MonitorMay 17, 2023
K212206abbott (st. jude medical)Jot Dx Insertable Cardiac MonitorAugust 13, 2021
K202876abbott (st. jude medical)Confirm Rx Insertable Cardiac MonitorDecember 1, 2020
K202888abbott (st. jude medical)Confirm Rx Insertable Cardiac MonitorNovember 23, 2020
K193310abbott (st. jude medical)myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)March 17, 2020
K192593abbottConfirm Rx Insertable Cardiac MonitorOctober 18, 2019
K190295abbott (st. jude medical)Confirm Rx Insertable Cardiac MonitorApril 10, 2019
K182981abbottConfirm Rx Insertable Cardiac MonitorMarch 29, 2019
K173232st jude medicalmyMerlin(TM) Mobile Application Model APP1001November 2, 2017
K163407st. jude medicalConfirm Rx Insertable Cardiac Monitor (ICM) SystemSeptember 29, 2017
K133481st. jude medicalSJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)May 28, 2014
K122161st jude medicalSJM CONFIRMNovember 28, 2012
K122090st. jude medical, cardiac rhythm management divisiSJM CONFIRM IMPLANTABLE CARDIAC MONITORNovember 15, 2012
K101968st jude medicalSJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100ASeptember 15, 2010
K091206transoma medicalSLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGMay 18, 2009
K083828transomaSLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONALFebruary 11, 2009
K081365st jude medicalSJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT AAugust 15, 2008
K073147transoma medicalSLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08December 3, 2007
K063035transnoma medicalSLEUTH IMPLANTABLE ECG MONITORING SYSTEMOctober 1, 2007
K011098medtronic vascularREVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND May 4, 2001