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510(k) Data Aggregation
K Number
K151246Device Name
Aneroid Sphygmomanometer
Manufacturer
Date Cleared
2015-06-30
(50 days)
Product Code
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
Jiaxing Zhongfa Medical Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Aneroid Sphygmomanometer is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users over age 18 at hospitals or at home to monitor both systolic and diastolic pressure.
Device Description
The Aneroid Sphygmomanometer with stethoscope is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This non-automated sphygmomanometer uses an occluding cuff, an sphygmomanometer to measure pressure and a stethoscope for detecting Korotkoff sounds.
The Aneroid Syphygmomanometer contains:
a. Blood Pressure Cuff
b. Stethoscope, which is use to detect the Korotkoff sounds;
c. Rotary Pin, 300 mmHg gauge, which is use to indicate the measurement result;
d. Air pump bulb, which is use to inflate the blood pressure cuff;
e. User Manual, which is use to instruct the user;
The Aneroid Sphygmomanometer with Stethoscope enables the user to monitor the pressure of flowing blood that is exerted against the arteries at highest (systolic or contraction) and lowest (diastolic or relaxation) pressure.
The proposed device has three models, ZF-113/ZF-114/ZF-115, in this submission, the three models has same intended use, same design and measuring principle, same accessories and same measuring range. The only difference between the models is appearance of gauge.
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