BEUDAMED
    Product Code: MPE FDA class 2 21 CFR 870.5550

    Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker

    Cardiovascular

    The Auxiliary Power Supply (AC or DC) for External Transcutaneous Cardiac Pacemakers is a cardiovascular accessory providing backup power to external transcutaneous pacemakers used in patients with life-threatening bradyarrhythmias or cardiac arrest. Classified as FDA Class 2 under 21 CFR 870.5550, it requires 510(k) premarket notification. The product code is MPE, and it carries a life-sustaining support flag reflecting its critical role in cardiac pacing.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MPE
    Device Class
    FDA class 2
    Regulation Number
    870.5550
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K945511 LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR