FDA.report

510(k) K202888

Device
Confirm Rx Insertable Cardiac Monitor
Applicant
Abbott (St. Jude Medical)
510(k) number
K202888
Product code
MXC
Decision
Substantially Equivalent (SESE)
Decision date
2020-11-23
Date received
2020-09-28
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

Related Records

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

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K230286Assert-IQ™ Insertable Cardiac MonitorABBOTT MEDICAL2023-05-17
K212206Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical)2021-08-13
K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)2020-12-01
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