BEUDAMED
    Product Code: DRZ FDA class 2 21 CFR 870.2675

    Oscillometer

    Cardiovascular

    The Oscillometer is a cardiovascular diagnostic device used to measure arterial blood pressure and peripheral vascular conditions by detecting oscillations in a cuff placed around a limb as the cuff pressure is varied. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRZ and it is regulated under 21 CFR 870.2675 within the Cardiovascular medical specialty.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    DRZ
    Device Class
    FDA class 2
    Regulation Number
    870.2675
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.