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

    PRESSURE MONITOR, MODEL 1131B

    K Number: K801110 · Decision May 20, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    76
    Applicant Total
    35
    Review Days
    8

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    Basic Information

    Device Name
    PRESSURE MONITOR, MODEL 1131B
    K Number
    K801110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1110
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    American Optical Corp.
    Date Received
    May 12, 1980
    Decision Date
    May 20, 1980
    Product Code
    DSK
    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
    DSK Computer, Blood-Pressure

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