BEUDAMED
    Product Code: QAB FDA class 2 21 CFR 870.3605

    Pacing System Analyzer

    Cardiovascular

    The Pacing System Analyzer is a cardiovascular diagnostic device intended to supply an accurately calibrated, variable pacing pulse for measuring a patient's pacing threshold and intracardiac R-wave potential, used during implantation or testing of cardiac pacing systems. It may be configured as a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing leads. It is classified as a Class 2 device under regulation 870.3605, requiring 510(k) premarket notification, and is flagged as life-sustaining given its role in supporting cardiac pacing. The product code is QAB, within the Cardiovascular (CV) medical specialty.

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    510(k)s
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    FEI Numbers
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    Registration Numbers
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    Unique Applicants
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    Years Active
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    Basic Information

    Product Code
    QAB
    Device Class
    FDA class 2
    Regulation Number
    870.3605
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

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

    Definition

    The device is intended to supply an accurately calibrated, variable pacing pulse for measuring the patient’s pacing threshold and intracardiac R-wave potential. A pacing system analyzer (PSA) may be a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing leads.