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

    BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193

    K Number: K032568 · Decision Apr 29, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    1
    Review Days
    253

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    Basic Information

    Device Name
    BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193
    K Number
    K032568
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Med Textile, LLC
    Date Received
    August 20, 2003
    Decision Date
    April 29, 2004
    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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