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510(k) K243115

Device
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D,
Applicant
Shenzhen Urion Technology Co., Ltd.
510(k) number
K243115
Product code
DXN
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-21
Date received
2024-09-30
Regulation
870.1130
Classification name
System, Measurement, Blood-Pressure, Non-Invasive
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Janice Ou
Address
Floor 4-6th Of Bldg. D, Jiale Science & Technology Indust Rial Zone, #3, Chuang Wei Rd., Heshuikou Community, Mati Shenzhen CN 518106 518106

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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