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FDA 510(k)

Full Automatic (NIBP) Blood Pressure Monitor

K-Number: K153214 · 2016-01-07

ApplicantHealth & Life Co., Ltd.
Decision Date2016-01-07
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Full Automatic (NIBP) Blood Pressure Monitor is a medical device manufactured by Health & Life Co., Ltd.. It received FDA 510(k) clearance on 2016-01-07 under approval number K153214. 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?

Full Automatic (NIBP) Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-01-07. It is manufactured by Health & Life Co., Ltd.. The 510(k) number is K153214.

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

Full Automatic (NIBP) Blood Pressure Monitor received FDA 510(k) clearance on 2016-01-07, under approval number K153214.

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

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

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

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

Related Clinical Trials

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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: 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 K180240Full Automatic(NIBP) Blood Pressure Monitor

View all 13 devices →

Related Devices (Code: DXN)

K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd. K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceGuangdong Transtek Medical Electronics Co., Ltd.

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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