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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?
    Applicant Name (Manufacturer) :

    MICRO DIRECT, INC.

    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
    K031102
    Device Name
    MICROLAB SPIROMETER
    Manufacturer
    MICRO DIRECT, INC.
    Date Cleared
    2003-12-01

    (238 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DIRECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlab spirometer is intended, for prescription use rno Mioreleb ope the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments.
    Device Description
    The Microlab spirometry systems consists of the Microlab spirometer, digital volume transducer, transducer housing, AC power adapter, power supply cord, disposable cardboard mouthpieces, carrying case, quick start guide and operators manual. Optional accessories include calibration syringe, nose clips, serial cable and a serial to parallel converter for use of an external compatible printer.
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    K Number
    K030586
    Device Name
    MICROPEAK
    Manufacturer
    MICRO DIRECT, INC.
    Date Cleared
    2003-08-27

    (184 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DIRECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended device simply measures a patient's peak expiratory flow rate in liters/minute. This is helpful in monitoring respiratory conditions such as asthma.
    Device Description
    A peak flow meter is a device used to measure a person's peak expiratory flow rate.
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    K Number
    K973314
    Device Name
    SPIROSAFE FILTER
    Manufacturer
    MICRO DIRECT, INC.
    Date Cleared
    1997-11-21

    (79 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DIRECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To filter possible bacteria and viruses from the patient exhalation when performing pulmonary function testing
    Device Description
    A disposable bacterial/viral filter used in pulmonary function testing
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    K Number
    K965042
    Device Name
    MICRODL DIARYCARD SPIROMETER
    Manufacturer
    MICRO DIRECT, INC.
    Date Cleared
    1997-06-17

    (182 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DIRECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To measure lung functions - FEV 1 , FVC, and PEF and to effect historical serial transfer of measured test indices to PC compatible computers
    Device Description
    A hand-held portable electronic spirometer measuring FEV1, FVC, and PEF.
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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?
    Applicant Name (Manufacturer) :

    MICRO DIRECT, INC.

    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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    K Number
    K963035
    Device Name
    MICRO SPIROMETER
    Manufacturer
    MICRO DIRECT, INC.
    Date Cleared
    1996-11-01

    (88 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DIRECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended device takes spirometer readings of a patient during exhalation. The output readings are FEV1 and FVC.
    Device Description
    A hand-held portable electronic spirometer measuring FEV1 and FVC
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    K Number
    K950197
    Device Name
    MICROCO
    Manufacturer
    MICRO DIRECT, INC.
    Date Cleared
    1996-10-17

    (638 days)

    Product Code
    CCJ
    Regulation Number
    868.1430
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO DIRECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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