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

    MODEL UCA / SPEC SYSTEM UCA

    K Number: K875305 · Decision Jan 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    MODEL UCA / SPEC SYSTEM UCA
    K Number
    K875305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Spec Systems, Inc.
    Date Received
    December 29, 1987
    Decision Date
    January 27, 1988
    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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