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FDA 510(k)

Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579

K-Number: K170866 · 2018-02-21

ApplicantHonsun (Nantong) Co., Ltd.
Decision Date2018-02-21
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 is a medical device manufactured by Honsun (Nantong) Co., Ltd.. It received FDA 510(k) clearance on 2018-02-21 under approval number K170866. 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 Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579?

Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 is a medical device that received FDA 510(k) clearance on 2018-02-21. It is manufactured by Honsun (Nantong) Co., Ltd.. The 510(k) number is K170866.

When was Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 approved by the FDA?

Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 received FDA 510(k) clearance on 2018-02-21, under approval number K170866.

What company makes Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579?

Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 is manufactured by Honsun (Nantong) Co., Ltd..

What is the FDA product code for Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579?

The FDA product code for Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 is DXN.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) 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: 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: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025)

Other Devices by Honsun (Nantong) Co., Ltd.

K170466Automatic Blood Pressure Monitor Model LD-518 & LD-537 K170454Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U K192500Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer K211629Infrared forehead thermometer LD-FT-100B K251795Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) K260260Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)

View all 7 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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