BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    SPIROTEQ

    K Number: K894556 · Decision Jan 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    227
    Applicant Total
    1
    Review Days
    173

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    Basic Information

    Device Name
    SPIROTEQ
    K Number
    K894556
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    System Analysis Corp.
    Date Received
    July 20, 1989
    Decision Date
    January 9, 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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