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FDA 510(k)

Automatic Blood Pressure Monitor Model LD-518 & LD-537

K-Number: K170466 · 2017-10-27

ApplicantHonsun (Nantong) Co., Ltd.
Decision Date2017-10-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Automatic Blood Pressure Monitor Model LD-518 & LD-537 is a medical device manufactured by Honsun (Nantong) Co., Ltd.. It received FDA 510(k) clearance on 2017-10-27 under approval number K170466. 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 Automatic Blood Pressure Monitor Model LD-518 & LD-537?

Automatic Blood Pressure Monitor Model LD-518 & LD-537 is a medical device that received FDA 510(k) clearance on 2017-10-27. It is manufactured by Honsun (Nantong) Co., Ltd.. The 510(k) number is K170466.

When was Automatic Blood Pressure Monitor Model LD-518 & LD-537 approved by the FDA?

Automatic Blood Pressure Monitor Model LD-518 & LD-537 received FDA 510(k) clearance on 2017-10-27, under approval number K170466.

What company makes Automatic Blood Pressure Monitor Model LD-518 & LD-537?

Automatic Blood Pressure Monitor Model LD-518 & LD-537 is manufactured by Honsun (Nantong) Co., Ltd..

What is the FDA product code for Automatic Blood Pressure Monitor Model LD-518 & LD-537?

The FDA product code for Automatic Blood Pressure Monitor Model LD-518 & LD-537 is DXN.

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Related PubMed Literature

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

K170454Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U K170866Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 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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