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

    FUKUDA DENSHI MODEL SPIROSIFT 3000

    K Number: K900391 · Decision Apr 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    227
    Applicant Total
    68
    Review Days
    74

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    Basic Information

    Device Name
    FUKUDA DENSHI MODEL SPIROSIFT 3000
    K Number
    K900391
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Fukuda Denshi USA, Inc.
    Date Received
    January 26, 1990
    Decision Date
    April 10, 1990
    Product Code
    BZG
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BZG Spirometer, Diagnostic

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