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

    CAIRD TECHNOLOGY SPIROMETER

    K Number: K971336 · Decision Dec 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    226
    Applicant Total
    3
    Review Days
    600

    Basic Information

    Device Name
    CAIRD TECHNOLOGY SPIROMETER
    K Number
    K971336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    CAIRD TECHNOLOGY
    Date Received
    April 10, 1997
    Decision Date
    December 1, 1998
    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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