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510(k) Data Aggregation
K Number
K122810Device Name
COMPACT DIGITAL BLOOD PRESSURE MONITOR
Manufacturer
Date Cleared
2013-02-08
(148 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
THERMOR LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Compact Blood Pressure Monitor is intended to measure the systolic, diastolic and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The device is reusable and intended for home use on adults.
Device Description
The Compact Blood Pressure Monitor, model BD204 is designed to measure systolic and diastolic blood pressure and pulse rate of an individual adult by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Rather than using the ausculatory method, which employs either an aneroid gauge or mercury manometer with a stethoscope to determine systolic and diastolic pressure, the device uses the oscillometric method, wherein an electronic semiconductor - sensor in the cuff determines the measurements. The sensor converts minute alterations in cuff pressure to electrical signals, by analyzing the amplitude of those signals systolic and diastolic pressure and pulse rates are calculated. The device analyses the signals and displays the results immediately.
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