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510(k) Data Aggregation
K Number
K090307Device Name
DDI ULTRASONIC NEBULIZER SYSTEM
Manufacturer
DIAGNOSTIC DEVICES, INC.
Date Cleared
2009-06-18
(132 days)
Product Code
CAF, DEV
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DDI Ultrasonic Nebulizer System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings.
Device Description
The DDI Ultrasonic Nebulizer System is a mesh screen ultrasonic nebulizer that operates in an identical fashion as other mesh screen nebulizers. The device creates aerosols of liquid medication by ejection of droplets from a mesh vibrated at ultrasonic frequencies and provide fine particles to the patient's lungs. The DDI Ultrasonic Nebulizer System is powered by a cable connecting to a 115 VAC power source with the AC adapter or two AA alkaline batteries.
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K Number
K060467Device Name
PRODIGY BLOOD GLUCOSE TEST SYSTEM
Manufacturer
DIAGNOSTIC DEVICES, INC.
Date Cleared
2006-07-13
(140 days)
Product Code
NBW, CGA, JJX
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Prodigy Blood Glucose Test System is intended for use in the quantitative measurement of glucose in capillary whole blood from the fingertip and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.
Device Description
The Prodigy glucose test system consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions. The system also provides voice broadcast function when the meter is used to test.
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