BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    UMSC HOLTER MONITORING KIT

    K Number: K872087 · Decision Jun 19, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    1
    Review Days
    18

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    Basic Information

    Device Name
    UMSC HOLTER MONITORING KIT
    K Number
    K872087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    United Medical Supply Co., Inc.
    Date Received
    June 1, 1987
    Decision Date
    June 19, 1987
    Product Code
    DSH
    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
    DSH Recorder, Magnetic Tape, Medical

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