Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)

System, Measurement, Blood-pressure, Non-invasive

Shenzhen Finicare Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Finicare Co., Ltd. with the FDA for Upper Arm Electronic Blood Pressure Monitor(model Fc-bp100,fc-bp101,fc-bp102,fc-bp110,fc-bp111,fc-bp112).

Pre-market Notification Details

Device IDK220113
510k NumberK220113
Device Name:Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Shenzhen Finicare Co., Ltd. 201, No.50, The 3rd Industrial Park, Houting Community, Shajing Street, Bao'an District Shenzhen,  CN 518104
ContactChao Li
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Shanghai,  CN 200120
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-14
Decision Date2022-05-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06971522820329 K220113 000
06971522820312 K220113 000
06971522820305 K220113 000
06971522820299 K220113 000
06971522820282 K220113 000
06971522820275 K220113 000
06971522820268 K220113 000
06971522820251 K220113 000
06971522820244 K220113 000

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