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Found 8 results
510(k) Data Aggregation
K Number
K033688Device 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
862.1820Why 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
K031102Device Name
MICROLAB SPIROMETER
Manufacturer
MICRO DIRECT, INC.
Date Cleared
2003-12-01
(238 days)
Product Code
BZG
Regulation Number
868.1840Why 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
K030586Device Name
MICROPEAK
Manufacturer
MICRO DIRECT, INC.
Date Cleared
2003-08-27
(184 days)
Product Code
BZH
Regulation Number
868.1860Why 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
K973314Device Name
SPIROSAFE FILTER
Manufacturer
MICRO DIRECT, INC.
Date Cleared
1997-11-21
(79 days)
Product Code
CAH
Regulation Number
868.5260Why 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
K965042Device Name
MICRODL DIARYCARD SPIROMETER
Manufacturer
MICRO DIRECT, INC.
Date Cleared
1997-06-17
(182 days)
Product Code
BZG
Regulation Number
868.1840Why 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
K963376Device Name
MICRO H2
Manufacturer
MICRO DIRECT, INC.
Date Cleared
1997-01-24
(150 days)
Product Code
NRH
Regulation Number
862.1820Why 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
K963035Device Name
MICRO SPIROMETER
Manufacturer
MICRO DIRECT, INC.
Date Cleared
1996-11-01
(88 days)
Product Code
BZG
Regulation Number
868.1840Why 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
K950197Device Name
MICROCO
Manufacturer
MICRO DIRECT, INC.
Date Cleared
1996-10-17
(638 days)
Product Code
CCJ
Regulation Number
868.1430Why 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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