Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Arm Electronic Sphygmomanometer

K-Number: K193387 · 2021-01-27

ApplicantShenzhen Changkun Technology Co., Ltd.
Decision Date2021-01-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arm Electronic Sphygmomanometer is a medical device manufactured by Shenzhen Changkun Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-01-27 under approval number K193387. 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 Electronic Sphygmomanometer?

Arm Electronic Sphygmomanometer is a medical device that received FDA 510(k) clearance on 2021-01-27. It is manufactured by Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K193387.

When was Arm Electronic Sphygmomanometer approved by the FDA?

Arm Electronic Sphygmomanometer received FDA 510(k) clearance on 2021-01-27, under approval number K193387.

What company makes Arm Electronic Sphygmomanometer?

Arm Electronic Sphygmomanometer is manufactured by Shenzhen Changkun Technology Co., Ltd..

What is the FDA product code for Arm Electronic Sphygmomanometer?

The FDA product code for Arm Electronic Sphygmomanometer is DXN.

Other Devices by Shenzhen Changkun Technology Co., Ltd.

K193253Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 K193386Wrist Electronic Sphygmomanometer K231595Electric Breast Pump K221798Finger Pulse Oximeter, Model: X1906P K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)

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.

↑