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

    RESPIRATORY FLOW MODULE

    K Number: K833265 · Decision Nov 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    7
    Applicant Total
    10
    Review Days
    68

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    Basic Information

    Device Name
    RESPIRATORY FLOW MODULE
    K Number
    K833265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2550
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Thoratec Laboratories Corp.
    Date Received
    September 21, 1983
    Decision Date
    November 28, 1983
    Product Code
    JAX
    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
    JAX Pneumotachometer

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