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FDA 510(k)

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B

K-Number: K211288 · 2021-11-04

Decision Date2021-11-04
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B is a medical device manufactured by Microlife Intellectual Property GmbH. It received FDA 510(k) clearance on 2021-11-04 under approval number K211288. 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 Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B?

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B is a medical device that received FDA 510(k) clearance on 2021-11-04. It is manufactured by Microlife Intellectual Property GmbH. The 510(k) number is K211288.

When was Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B approved by the FDA?

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B received FDA 510(k) clearance on 2021-11-04, under approval number K211288.

What company makes Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B?

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B is manufactured by Microlife Intellectual Property GmbH.

What is the FDA product code for Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B?

The FDA product code for Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B is DXN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.