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

    DEVILBISS SUCTION UNIT

    K Number: K982304 · Decision Sep 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    76
    Applicant Total
    10
    Review Days
    86

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    Basic Information

    Device Name
    DEVILBISS SUCTION UNIT
    K Number
    K982304
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sunrise Medical Hhg, Inc.
    Date Received
    July 1, 1998
    Decision Date
    September 25, 1998
    Product Code
    JCX
    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
    JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered

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