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

    INFINITECH BREATH EZ

    K Number: K935441 · Decision Feb 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    19
    Applicant Total
    6
    Review Days
    87

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    Basic Information

    Device Name
    INFINITECH BREATH EZ
    K Number
    K935441
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Infinitech, Inc.
    Date Received
    November 12, 1993
    Decision Date
    February 7, 1994
    Product Code
    BWN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BWN Table And Attachments, Operating-Room

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