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

    APEXLINE OF PULMONARY FUNCT. INSTRUM.

    K Number: K803053 · Decision Dec 22, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    14
    Review Days
    20

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    Basic Information

    Device Name
    APEXLINE OF PULMONARY FUNCT. INSTRUM.
    K Number
    K803053
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Warren E. Collins, Inc.
    Date Received
    December 2, 1980
    Decision Date
    December 22, 1980
    Product Code
    BTY
    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
    BTY Calculator, Predicted Values, Pulmonary Function

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