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

    LOSS OF RESISTANCE SYRINGE

    K Number: K061737 · Decision Dec 18, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    154
    Applicant Total
    1
    Review Days
    181

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    Basic Information

    Device Name
    LOSS OF RESISTANCE SYRINGE
    K Number
    K061737
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5140
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Robert Busse & Co., Inc.
    Date Received
    June 20, 2006
    Decision Date
    December 18, 2006
    Product Code
    CAZ
    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
    CAZ Anesthesia Conduction Kit

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