Digital Blood Pressure Monitor (Model: YB-800)
K-Number: K231478 · 2023-12-15
Decision Date2023-12-15
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Digital Blood Pressure Monitor (Model: YB-800) is a medical device manufactured by Wenzhou Yosun Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-12-15 under approval number K231478. 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 Digital Blood Pressure Monitor (Model: YB-800)?
Digital Blood Pressure Monitor (Model: YB-800) is a medical device that received FDA 510(k) clearance on 2023-12-15. It is manufactured by Wenzhou Yosun Medical Technology Co.,Ltd. The 510(k) number is K231478.
When was Digital Blood Pressure Monitor (Model: YB-800) approved by the FDA?
Digital Blood Pressure Monitor (Model: YB-800) received FDA 510(k) clearance on 2023-12-15, under approval number K231478.
What company makes Digital Blood Pressure Monitor (Model: YB-800)?
Digital Blood Pressure Monitor (Model: YB-800) is manufactured by Wenzhou Yosun Medical Technology Co.,Ltd.
What is the FDA product code for Digital Blood Pressure Monitor (Model: YB-800)?
The FDA product code for Digital Blood Pressure Monitor (Model: YB-800) 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.