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

    CUFFABLE

    K Number: K911213 · Decision Aug 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    10
    Review Days
    141

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    Basic Information

    Device Name
    CUFFABLE
    K Number
    K911213
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Biomedical Dynamics, Inc.
    Date Received
    March 19, 1991
    Decision Date
    August 7, 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 Biomedical Dynamics, Inc.

    K Number Device Name
    K915074 IRRIGATOR/ASPIRATOR PROBE
    K913751 PRESSURE INFUSER
    K911216 INFUSABLE
    K911324 IRRIGATION/ASPIRATION TUBING SET
    K904376 ANEROID BLOOD PRESSURE GAUGE
    K890268 PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION
    K881799 BLOOD PRESSURE CUFF
    K861977 BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR
    K850506 CORRECT FLO INTRAVASCULAR ADMINISTRATION SET