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

    SPIRO-FLEX

    K Number: K945565 · Decision Jan 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    199
    Registration Numbers
    199
    Same Product Code
    183
    Applicant Total
    7
    Review Days
    119

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    Basic Information

    Device Name
    SPIRO-FLEX
    K Number
    K945565
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5240
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inhalation Plastics
    Date Received
    September 16, 1994
    Decision Date
    January 13, 1995
    Product Code
    CAI
    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
    CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

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