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FDA 510(k)

Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B

K-Number: K201467 · 2020-09-21

ApplicantBioland Technology, Ltd.
Decision Date2020-09-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B is the device name listed in this FDA 510(k) record. The listed applicant is Bioland Technology, Ltd.. It received FDA 510(k) clearance on 2020-09-21 under 510(k) number K201467. 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 Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B?

Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B is a medical device that received FDA 510(k) clearance on 2020-09-21. The listed applicant is Bioland Technology, Ltd.. The 510(k) number is K201467.

When did Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B receive FDA 510(k) clearance?

Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B received FDA 510(k) clearance on 2020-09-21, under 510(k) number K201467.

Who is the listed applicant for Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B?

The FDA 510(k) record lists Bioland Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B?

The FDA product code for Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B 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.

NCT06969560WeRoaM: 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 Bioland Technology, 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.

K202739Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring SystemK213011Infrared Thermometer (model: E201)K201879Digital Thermometer Model T103, T104K202934Blood Pressure MonitorK201161Infrared Thermometer Model E127K191657Bioland Blood Glucose Monitoring System

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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

View on FDA Database →

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

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