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

    VITA-STAT MODEL 900A

    K Number: K792192 · Decision Nov 13, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    5
    Review Days
    12

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    Basic Information

    Device Name
    VITA-STAT MODEL 900A
    K Number
    K792192
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Vita-Stat Medical Services, Inc.
    Date Received
    November 1, 1979
    Decision Date
    November 13, 1979
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    Other Clearances by Vita-Stat Medical Services, Inc.

    K Number Device Name
    K830713 LS-1 PORTABLE BLOOD PRESSURE COMPUTER
    K830368 AMBULATORY BLOOD PRESSURE MONITOR
    K792193 VITA-STAT MODEL 900-D
    K792194 VITA-STAT MODEL 900-S