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

    BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF

    K Number: K912007 · Decision Jul 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    5
    Review Days
    77

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    Basic Information

    Device Name
    BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF
    K Number
    K912007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tecnadyne Scientific, Inc.
    Date Received
    May 6, 1991
    Decision Date
    July 22, 1991
    Product Code
    DXQ
    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
    DXQ Blood Pressure Cuff

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    Other Clearances by Tecnadyne Scientific, Inc.

    K Number Device Name
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    K910926 TECNADYNE SURGI-SQUEEZE INFUSION PUMP
    K904484 BAXTER SINGLE PATIENT USE PRESSURE INFUSOR