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510(k) Data Aggregation
K Number
K062893Device Name
KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A
Date Cleared
2007-02-05
(131 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The blood pressure meter Models: XJ-2001AC, XJ-2002AS and XJ-2003A are non-invasive blood pressure measurement systems which are intended to measure the diastolic and systolic blood pressure, pulse rate of the adult individual through using inflatable cuff at home. The cuff circumference is limited to 8.6614 inches to 12.60 inches.
Device Description
Blood Pressure Meter Model: XJ-2001AC, XJ-2002AS and XJ-2003A
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