Fully Automatic Electronic Blood Pressure Monitor
K-Number: K162915 · 2017-02-08
ApplicantAndon Health Co, Ltd.
Decision Date2017-02-08
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Fully Automatic Electronic Blood Pressure Monitor is a medical device manufactured by Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2017-02-08 under approval number K162915. 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 Fully Automatic Electronic Blood Pressure Monitor?
Fully Automatic Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2017-02-08. It is manufactured by Andon Health Co, Ltd.. The 510(k) number is K162915.
When was Fully Automatic Electronic Blood Pressure Monitor approved by the FDA?
Fully Automatic Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2017-02-08, under approval number K162915.
What company makes Fully Automatic Electronic Blood Pressure Monitor?
Fully Automatic Electronic Blood Pressure Monitor is manufactured by Andon Health Co, Ltd..
What is the FDA product code for Fully Automatic Electronic Blood Pressure Monitor?
The FDA product code for Fully Automatic Electronic Blood Pressure Monitor is DXN.
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Other Devices by Andon Health Co, Ltd.
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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.