FDA 510(k)

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

K-Number: K201467 · 2020-09-21

Decision Date2020-09-21

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

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

When was Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B approved by the FDA?

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

What company makes Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B?

Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B is manufactured by Bioland Technology, Ltd..

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.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

Other Devices by Bioland Technology, Ltd.

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Related Devices (Code: DXN)

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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.