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510(k) Data Aggregation
K Number
K152415Device Name
Digital Blood Pressure Monitor
Manufacturer
Date Cleared
2016-05-06
(254 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
SUZHOU SUNSPIRIT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate.
The device is intended for use in only adult population, not applied to ther populations such as neonatal baby.
It can not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
Device Description
Digital Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method by inflating an inflatable cuff on the wrist. Digital Blood Pressure Monitor JWS-1000, JWS-970, JWS-950, JWS-940, JWS-706, JWS-705. JWS-704. JWS-703. JWS-701. JWS-700. JWS-600. BC20. BC40 have the same technology, main function, performance and intended use, and they are consistent in product structure and material.
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