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

    SEVOFLURANE VAPORIZER ADAPTOR

    K Number: K110608 · Decision Jul 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    56
    Applicant Total
    1
    Review Days
    139

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    Basic Information

    Device Name
    SEVOFLURANE VAPORIZER ADAPTOR
    K Number
    K110608
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Piramal Critcal Care, Inc (Formerly Minrad, Inc)
    Date Received
    March 3, 2011
    Decision Date
    July 20, 2011
    Product Code
    CAD
    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
    CAD Vaporizer, Anesthesia, Non-Heated

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