BEUDAMED
    Product Code: DQH FDA class 2 21 CFR 870.2310

    Cardiograph, Apex (Vibrocardiograph)

    Cardiovascular

    The Apex Cardiograph (Vibrocardiograph) is a non-invasive cardiovascular diagnostic device used to record mechanical vibrations of the chest wall at the cardiac apex, providing information about ventricular function and timing. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DQH and it is regulated under 21 CFR 870.2310 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    DQH
    Device Class
    FDA class 2
    Regulation Number
    870.2310
    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
    K974697 REUSABLE FINGER SENSOR 3444

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.