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510(k) Data Aggregation
K Number
K141392Device Name
SPHYGMOMANOMETER
Manufacturer
Date Cleared
2014-07-02
(36 days)
Product Code
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
SUZHOU JJ METER CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. 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
The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure . The device tubing is connected to a non-invasive sphygmomanometer.
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