FDA 510(k)

Arm-Type Fully Automatic Digital Blood Pressure Monitor

K-Number: K161577 · 2017-02-08

ApplicantSejoy Electronics & Instruments Co., Ltd.

Decision Date2017-02-08

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Arm-Type Fully Automatic Digital Blood Pressure Monitor is a medical device manufactured by Sejoy Electronics & Instruments Co., Ltd.. It received FDA 510(k) clearance on 2017-02-08 under approval number K161577. 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 Arm-Type Fully Automatic Digital Blood Pressure Monitor?

Arm-Type Fully Automatic Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2017-02-08. It is manufactured by Sejoy Electronics & Instruments Co., Ltd.. The 510(k) number is K161577.

When was Arm-Type Fully Automatic Digital Blood Pressure Monitor approved by the FDA?

Arm-Type Fully Automatic Digital Blood Pressure Monitor received FDA 510(k) clearance on 2017-02-08, under approval number K161577.

What company makes Arm-Type Fully Automatic Digital Blood Pressure Monitor?

Arm-Type Fully Automatic Digital Blood Pressure Monitor is manufactured by Sejoy Electronics & Instruments Co., Ltd..

What is the FDA product code for Arm-Type Fully Automatic Digital Blood Pressure Monitor?

The FDA product code for Arm-Type Fully Automatic Digital Blood Pressure Monitor is DXN.

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Related PubMed Literature

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Other Devices by Sejoy Electronics & Instruments Co., Ltd.

K153149Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 K153146Infrared Ear Thermometer

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.