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

    KOKO SPIROMETER

    K Number: K914272 · Decision Jul 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    227
    Applicant Total
    2
    Review Days
    282

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    Basic Information

    Device Name
    KOKO SPIROMETER
    K Number
    K914272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ferraris Respiratory, Inc.
    Date Received
    September 24, 1991
    Decision Date
    July 2, 1992
    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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    Other Clearances by Ferraris Respiratory, Inc.

    K Number Device Name
    K022276 KOKOMATE