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

    SMITH & NEPHEW DYONICS LEVELERT SYSTEM

    K Number: K903193 · Decision Aug 30, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    38
    Applicant Total
    22
    Review Days
    42

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    Basic Information

    Device Name
    SMITH & NEPHEW DYONICS LEVELERT SYSTEM
    K Number
    K903193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2420
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Smith & Nephew Dyonics, Inc.
    Date Received
    July 19, 1990
    Decision Date
    August 30, 1990
    Product Code
    FLN
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLN Monitor, Electric For Gravity Flow Infusion Systems

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