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510(k) Data Aggregation
K Number
K032308Device Name
BLOOD PRESSURE MONITOR, MODEL M100
Manufacturer
Date Cleared
2003-11-10
(108 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
MEDITEK TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The M100 of blood pressure monitor is an electronic device that provides a signal from which the systolic, diastolic and rate of heart beats can be derived through the use of transducers placed on the surface of the body. The signals of measurement can be stored in the memory of device, and then can be displayed on the screen of device and/or be transmitted out of device by using the standard signal transmission cable.
Device Description
The Meditek Blood Pressure Monitor, model M100, is the non-invasive electronic medical device intended for the measuring of blood pressure (including systolic pressure and diastolic pressure) and the number of heart beats of patient by using the oscillometric method. According to the general principle of the oscillometric method, the cuff was placed on patient's wrist or arm. The cuff was inflated by using pneumatic pump to the estimated pressure and then was deflated at a certain deflation rate. During the deflation of pressure, the pressure and it's oscillation was measured. The measuring pressure and its oscillation are calculated and analysed by the software of the microprocessor according to the algorithm of oscillometric method.
After completing the measuring cycle, the systolic pressure, diastolic pressure, and heart beat rate are displayed on the LCD of device. All the measuring information and the time of measuring may be stored in the memories of device. Those stored memories may be transmitted out of device through the signal transmission cable.
Basically the blood pressure monitor M100 is the device measuring blood pressure at wrist.
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