BEUDAMED
    Product Code: PMJ FDA class 2 21 CFR 870.5210

    Cpr Aid Feedback Device (No Software)

    Cardiovascular

    The CPR Aid Feedback Device (No Software) (product code PMJ) is a Class 2 cardiovascular device that provides real-time audio and/or visual feedback to rescuers regarding the quality of CPR being delivered, encouraging consistent application of effective manual CPR in accordance with current guidelines, regulated under 870.5210. It requires 510(k) clearance and falls under the cardiovascular medical specialty. The device is not an implant and is not life-sustaining.

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

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    Basic Information

    Product Code
    PMJ
    Device Class
    FDA class 2
    Regulation Number
    870.5210
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    4

    Device Characteristics

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

    Definition

    Provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.