BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    CPR BAND

    K Number: K201581 · Decision Mar 6, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    268

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    Basic Information

    Device Name
    CPR BAND
    K Number
    K201581
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Credo
    Date Received
    June 11, 2020
    Decision Date
    March 6, 2021
    Product Code
    LIX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LIX Aid, Cardiopulmonary Resuscitation

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