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

    BRONCHODILATOR TEE - 9056 SERIES

    K Number: K873521 · Decision Mar 2, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    38
    Review Days
    183

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    Basic Information

    Device Name
    BRONCHODILATOR TEE - 9056 SERIES
    K Number
    K873521
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Boehringer Laboratories
    Date Received
    September 1, 1987
    Decision Date
    March 2, 1988
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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