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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 a medical device manufactured by Health & Life Co., Ltd.. It received FDA 510(k) clearance on 2021-09-08 under approval 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. It is manufactured by Health & Life Co., Ltd.. The 510(k) number is K211127.

When was Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM approved by the FDA?

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

What company makes Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM?

Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM is manufactured by Health & Life Co., Ltd..

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.

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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) PMID: 40406702 Toward a unified gait freeze index: a standardized benchmark for clinical and regulatory evaluations. Frontiers in neurology (2025)

Other Devices by Health & Life Co., Ltd.

K162338Full Automatic (NIBP) Blood Pressure Monitor K160557Full Automatic (NIBP) Blood Pressure Monitor K161156Full Automatic (NIBP) Blood Pressure Monitor K160336Full Automatic (NIBP) Blood Pressure Monitor K160145Full Automatic (NIBP) Blood Pressure Monitor K153214Full Automatic (NIBP) Blood Pressure Monitor

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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.

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