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510(k) Data Aggregation
K Number
K070209Device Name
FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR
Manufacturer
Date Cleared
2007-08-08
(198 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
FEGO PRECISION INDUSTRIAL CO; LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
FB-100U Series Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm. The device is indicated for use by people over 15 years old in home use.
Device Description
FB-100U Series DIGITAL Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual). All values can be read out in one LCD DISPLAY. Measurement position is on adult arm only.
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