Wrist Electronic Sphygmomanometer
K-Number: K193386 · 2021-01-27
Decision Date2021-01-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Wrist 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 K193386. 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 Wrist Electronic Sphygmomanometer?
Wrist 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 K193386.
When was Wrist Electronic Sphygmomanometer approved by the FDA?
Wrist Electronic Sphygmomanometer received FDA 510(k) clearance on 2021-01-27, under approval number K193386.
What company makes Wrist Electronic Sphygmomanometer?
Wrist Electronic Sphygmomanometer is manufactured by Shenzhen Changkun Technology Co., Ltd..
What is the FDA product code for Wrist Electronic Sphygmomanometer?
The FDA product code for Wrist Electronic Sphygmomanometer is DXN.
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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.