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

    HTS *1

    K Number: K822843 · Decision Dec 15, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    76
    Applicant Total
    1
    Review Days
    83

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    Basic Information

    Device Name
    HTS *1
    K Number
    K822843
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1110
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Global Office Automation System, Inc.
    Date Received
    September 23, 1982
    Decision Date
    December 15, 1982
    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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