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510(k) Data Aggregation

    K Number
    K033688
    Device Name
    MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
    Manufacturer
    MICRO DIRECT, INC.
    Date Cleared
    2004-05-19

    (177 days)

    Product Code
    NRH
    Regulation Number
    862.1820
    Why did this record match?
    Product Code :

    NRH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micro H2 is a hand held hydrogen monitor used in the screening and diagnosis of lactose malabsorption, a condition that produces increased hydrogen levels in the blood when unabsorbed lactose reacts with bacteria in the intestines. This increased level of hydrogen is expired and can be measured after ingestion of lactose following a period of fasting. Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician. Target Population: Adult, Child and Infant.
    Device Description
    The Micro H2 Breath Monitoring device is a battery operated hand held hydrogen breath monitor. Clinicians using this device have a patient expel their breath into an inlet port through a disposable mouthpiece adapter. The hydrogen concentration is then displayed in parts per million (ppm). The software utility, product name Hydra, will be supplied to purchasers of the breath hydrogen monitoring device. At the clinician's discretion, they can install Hydra on a Windows based PC. Thereafter, the handheld Micro H2 device can be connected to the PC via a serial communications cable to acquire and log successive breath hydrogen measurements during a diagnostic procedure.
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    K Number
    K963376
    Device Name
    MICRO H2
    Manufacturer
    MICRO DIRECT, INC.
    Date Cleared
    1997-01-24

    (150 days)

    Product Code
    NRH
    Regulation Number
    862.1820
    Why did this record match?
    Product Code :

    NRH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micro Hs is a hand held hydrogen monitor, used in the screening and diagnosis of lactose malabsorption, a condition that produces increased hydrogen levels in the blood when unabsorbed lactose reacts with bacteria in the intestines. This increased level of hydrogen is expired and can be measured after ingestion of lactose following a period of fasting.
    Device Description
    The Micro Hs is a hand held hydrogen monitor.
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