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

    WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM

    K Number: K930888 · Decision Jul 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    147
    Applicant Total
    2
    Review Days
    152

    Basic Information

    Device Name
    WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM
    K Number
    K930888
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    RALIN MEDICAL, INC.
    Date Received
    February 19, 1993
    Decision Date
    July 21, 1993
    Product Code
    DRS
    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
    DRS Transducer, Blood-Pressure, Extravascular

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