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

    PNEUMOTHERML, MODEL: 5800

    K Number: K092685 · Decision Nov 24, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    48
    Review Days
    83

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    Basic Information

    Device Name
    PNEUMOTHERML, MODEL: 5800
    K Number
    K092685
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Salter Labs
    Date Received
    September 2, 2009
    Decision Date
    November 24, 2009
    Product Code
    BZQ
    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
    BZQ Monitor, Breathing Frequency

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