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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K160019

U80 Series Upper Arm Electronic Blood Pressure Monitor · Shenzhen Urion Technology Co., Ltd. · decided 2016-04-22 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
ALPHAMEDU81CHShenzhen Urion Technology Co., LtdDXN06953825905804
EUPHU80KShenzhen Urion Technology Co., LtdDXN06953825903114
AccuroU80AHShenzhen Urion Technology Co., LtdDXN06953825901998
ZOETOUCHU80IShenzhen Urion Technology Co., LtdDXN06953825907273
ALphagoMedU80RShenzhen Urion Technology Co., LtdDXN06953825903145
ALPHAMEDU85HShenzhen Urion Technology Co., LtdDXN06953825904234
AthelasU807Shenzhen Urion Technology Co., LtdDXN06953825906085
Andesfit ADF-B61ANDESFIT LIMITEDDXN04897100310254
Baseline Evaluation InstrumentsU82VShenzhen Urion Technology Co., LtdDXN06953825907525
DrKumoU80MShenzhen Urion Technology Co., LtdDXN06953825903718
HEDIGONU80AHShenzhen Urion Technology Co., LtdDXN06953825908782
AlphaMedU90EShenzhen Urion Technology Co., LtdDXN06953825909765
(unnamed)U80AShenzhen Urion Technology Co., LtdDXN06953825908737
AmzdealU80KShenzhen Urion Technology Co., LtdDXN06953825903343
ALPHAMEDU81MShenzhen Urion Technology Co., LtdDXN06953825905019
Cerebral MedicalU80AHShenzhen Urion Technology Co., LtdDXN06953825901783
ArealerU80HShenzhen Urion Technology Co., LtdDXN06953825904647
LIVAROCIU81QShenzhen Urion Technology Co., LtdDXN06953825906436
ACCUROU807Shenzhen Urion Technology Co., LtdDXN06953825904975
JOOPHYSU81QHShenzhen Urion Technology Co., LtdDXN06953825904258
TENKERU80QShenzhen Urion Technology Co., LtdDXN06953825903299
AlphaMedU90FShenzhen Urion Technology Co., LtdDXN06953825909895
HylogyU81UShenzhen Urion Technology Co., LtdDXN06953825909017
TOVENDORU80RShenzhen Urion Technology Co., LtdDXN06953825904920
Dr.meter®U80BShenzhen Urion Technology Co., LtdFXN06953825902605