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FDA 510(k)

Fully Automatic Electronic Blood Pressure Monitor

K-Number: K162230 · 2016-11-18

ApplicantAdon Health Co., Ltd.
Decision Date2016-11-18
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fully Automatic Electronic Blood Pressure Monitor is a medical device manufactured by Adon Health Co., Ltd.. It received FDA 510(k) clearance on 2016-11-18 under approval number K162230. 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 2016-11-18. It is manufactured by Adon Health Co., Ltd.. The 510(k) number is K162230.

When was Fully Automatic Electronic Blood Pressure Monitor approved by the FDA?

Fully Automatic Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2016-11-18, under approval number K162230.

What company makes Fully Automatic Electronic Blood Pressure Monitor?

Fully Automatic Electronic Blood Pressure Monitor is manufactured by Adon 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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Related PubMed Literature

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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.

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