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510(k) Data Aggregation
K Number
K103046Device Name
HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE
Manufacturer
Date Cleared
2011-01-10
(88 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
HOSMAN INTERNATIONAL CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HOSMAN USB Blood Pressure Monitor, Upper Arm Type: HM-500 and Wrist Type: HM-100, are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist or upper arm. The cuff circumference is limited to be 5.3'~7.7' (13.5 cm~19.5 cm) for wrist type; and 8.7'~14.6' (22 cm~37 cm) for Upper Arm type.
Device Description
HOSMAN USB Blood Pressure Monitor Upper Arm Type: HM-500 and Wrist Type: HM-100 use the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
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