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FDA 510(k)

Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM

K-Number: K211127 · 2021-09-08

ApplicantHealth & Life Co., Ltd.
Decision Date2021-09-08
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM is the device name listed in this FDA 510(k) record. The listed applicant is Health & Life Co., Ltd.. It received FDA 510(k) clearance on 2021-09-08 under 510(k) number K211127. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM?

Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM is a medical device that received FDA 510(k) clearance on 2021-09-08. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K211127.

When did Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM receive FDA 510(k) clearance?

Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM received FDA 510(k) clearance on 2021-09-08, under 510(k) number K211127.

Who is the listed applicant for Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM?

The FDA 510(k) record lists Health & Life Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM?

The FDA product code for Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM is DXN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05524909Full-scale Intervention Study: Genetic Risk Communication and WearablesCOMPLETEDNCT05673408NIBP Validation StudyRECRUITINGNCT06508619Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation StudyCOMPLETEDNCT06969560WeRoaM: Wearable Remote Monitoring in Heart FailureRECRUITINGNCT07713576Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the ISO 81060-2:2018+AMD1:2020+AMD2:2024.COMPLETED

Other records listing Health & Life Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211744Non-Contact Infrared Thermometer, model HL710HK200521Full Automatic(NIBP) Blood Pressure MonitorK190507Full Automatic (NIBP) Blood Pressure MonitorK190133Full Automatic (NIBP) Blood Pressure Monitor-HL158UBK190134Full Automatic (NIBP) Blood Pressure Monitor-HL158TBK180240Full Automatic(NIBP) Blood Pressure Monitor

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Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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