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510(k) K230286

Device
Assert-IQ? Insertable Cardiac Monitor
Applicant
ABBOTT MEDICAL
510(k) number
K230286
Product code
MXC
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-17
Date received
2023-02-02
Regulation
870.2800
Classification name
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Laura Sparks
Address
15900 Valley View Ct. Sylmar CA US 91342 91342

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MXC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K212206Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical)2021-08-13
K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)2020-12-01
K202888Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)2020-11-23
K193310myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)Abbott (St. Jude Medical)2020-03-17
K192593Confirm Rx Insertable Cardiac MonitorAbbott2019-10-18
K190295Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)2019-04-10
K182981Confirm Rx Insertable Cardiac MonitorAbbott2019-03-29
K173232myMerlin(TM) Mobile Application Model APP1001St Jude Medical2017-11-02
K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.2017-09-29
K133481SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)St. Jude Medical, Inc.2014-05-28
K122161SJM CONFIRMSt Jude Medical2012-11-28
K122090SJM CONFIRM IMPLANTABLE CARDIAC MONITORSt. Jude Medical, Cardiac Rhythm Management Divisi2012-11-15
K101968SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100ASt Jude Medical2010-09-15
K091206SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODELTransoma Medical2009-05-18
K083828SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KITTransoma2009-02-11