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

    ULTRAFLOW

    K Number: K871901 · Decision Jun 1, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    17

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    Basic Information

    Device Name
    ULTRAFLOW
    K Number
    K871901
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Custom Industries, Inc.
    Date Received
    May 15, 1987
    Decision Date
    June 1, 1987
    Product Code
    FZH
    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
    FZH Apparatus, Air Handling, Room

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