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510(k) Data Aggregation
K Number
K192500Device Name
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
Manufacturer
Honsun(Nantong)Co.,Ltd
Date Cleared
2020-04-06
(207 days)
Product Code
DXQ, LDE
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
Honsun(Nantong)Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to be used by medical professionals or in the measurement of systolic and diastolic pressure. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
Device Description
Aneroid sphygmomanometer Model HS-20A,HS-20D,HS-201W, HS-201Y,HS-201C1, HS-201Q3/ Aneroid sphygmomanometer with stethoscope, Model HS-50C,HS-50B, HS-50D are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include cuff, inflation bulb, instruction manual and carrying case. Model HS-50C,HS-50D,HS-50B also include a stethoscope. It is conjunction with stethoscope when use.
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K Number
K170866Device Name
Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
Manufacturer
Honsun(Nantong)Co.,Ltd
Date Cleared
2018-02-21
(335 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Honsun(Nantong)Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scian Automatic Digital Blood Pressure Monitor LD-576, LD-579 are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
Device Description
Scian Automatic Digital Blood Pressure Monitor, Model LD-575, LD-576 and LD-579
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