BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM

    K Number: K071269 · Decision Aug 1, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    57
    Applicant Total
    52
    Review Days
    86

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    Basic Information

    Device Name
    HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
    K Number
    K071269
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.1100
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Smiths Medical Asd, Inc.
    Date Received
    May 7, 2007
    Decision Date
    August 1, 2007
    Product Code
    CBT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CBT Arterial Blood Sampling Kit

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