BEUDAMED
    Product Code: MXC FDA class 2 21 CFR 870.2800

    Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

    Cardiovascular

    An Implantable Cardiac Event Recorder Without Arrhythmia Detection is a small device surgically implanted subcutaneously that continuously records the patient's electrocardiogram over months to years, used to capture and store cardiac rhythm data during symptomatic episodes for later physician review, without automated arrhythmia detection algorithms. It is FDA Class 2, requiring 510(k) clearance, is an implant, with product code MXC under 21 CFR 870.2800 in the Cardiovascular specialty. The device is not life-sustaining.

    View on FDA
    510(k)s
    23
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    10
    Years Active
    25

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    Basic Information

    Product Code
    MXC
    Device Class
    FDA class 2
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 23 510(k) clearances via K numbers.

    K Number Device Name
    K230286 Assert-IQ™ Insertable Cardiac Monitor
    K212206 Jot Dx Insertable Cardiac Monitor
    K202876 Confirm Rx Insertable Cardiac Monitor
    K202888 Confirm Rx Insertable Cardiac Monitor
    K193310 myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)
    K192593 Confirm Rx Insertable Cardiac Monitor
    K190295 Confirm Rx Insertable Cardiac Monitor
    K182981 Confirm Rx Insertable Cardiac Monitor
    K173232 myMerlin(TM) Mobile Application Model APP1001
    K163407 Confirm Rx Insertable Cardiac Monitor (ICM) System
    K133481 SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
    K122161 SJM CONFIRM
    K122090 SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
    K101968 SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
    K091206 SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL
    K083828 SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT
    K081365 SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
    K073147 SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
    K063035 SLEUTH IMPLANTABLE ECG MONITORING SYSTEM
    K011098 REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
    K003667 REVEAL PLUS INSERTABLE LOOP RECORDER
    K994331 REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR
    K972242 REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.