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510(k) Data Aggregation
K Number
K043444Device Name
MULTIPLE, MODEL KTJ-50
Manufacturer
GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD.
Date Cleared
2005-02-22
(70 days)
Product Code
DXQ, DXN
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Multiple Brand, with model number KTJ-50, aneroid sphygmomanometer is an instrument intended to be used for the indirect (noninvasive) measurement of human's Systolic, Diastolic blood pressure using the auscultatory method by detecting Korotkoff Sound. This device is to be used by trained medical and health care personnel or trained general users.
Device Description
The aneroid sphygmomanometer with stethoscope is a non-invasive blood pressure measurement system for monitoring blood pressure levels which can be performed by trained individuals. The sphygmomanometer Model KTJ-50 consists of 5 parts. They are aneroid manometer, latex bulb, cuff, valve and stethoscope set. The aneroid sphygmomanometer with stethoscope enables the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the Korotkoff sound. After inflation of the user does auditory monitor with the stethoscope to evaluate systolic and diastolic pressure. The two values are recorded as: systolic over diastolic.
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K Number
K010686Device Name
KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C
Manufacturer
GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD.
Date Cleared
2001-03-21
(13 days)
Product Code
DXQ
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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