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510(k) Data Aggregation

    K Number
    K110608
    Device Name
    SEVOFLURANE VAPORIZER ADAPTOR
    Manufacturer
    PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC)
    Date Cleared
    2011-07-20

    (139 days)

    Product Code
    CAD
    Regulation Number
    868.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sevoflurane Vaporizer Adaptor is intended to be used by qualified personnel as a means of filling Sevoflurane from a Piramal Sevoflurane bottle into a user-owned QuikFil™ Sevoflurane vaporizer.
    Device Description
    The Sevoflurane Vaporizer Adaptor will fit securely to the bottle and the vaporizer, ensuring minimal leakage. The adaptor is designed for use with QuikFil™ vaporizer filling technology and it is intended for multiple uses. The device complies with the requirements of ISO 5360:2006.
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