BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)

    K Number: K900331 · Decision Sep 4, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    227
    Applicant Total
    1
    Review Days
    224

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    Basic Information

    Device Name
    TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)
    K Number
    K900331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Ghg Medizin-Elektronik AG
    Date Received
    January 23, 1990
    Decision Date
    September 4, 1990
    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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