BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HEART MONITOR BRACELET ALARM

    K Number: K822316 · Decision Sep 21, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    49

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    Basic Information

    Device Name
    HEART MONITOR BRACELET ALARM
    K Number
    K822316
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.2620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Hmba
    Date Received
    August 3, 1982
    Decision Date
    September 21, 1982
    Product Code
    DRI
    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
    DRI Monitor, Line Isolation

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