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

    PART NO. 66-00121

    K Number: K770928 · Decision May 26, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    227
    Applicant Total
    2
    Review Days
    6

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    Basic Information

    Device Name
    PART NO. 66-00121
    K Number
    K770928
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Harlake Cyprane
    Date Received
    May 20, 1977
    Decision Date
    May 26, 1977
    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 Harlake Cyprane

    K Number Device Name
    K770927 PART NO. 66-00311