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FDA 510(k)

A&D Medical UM-212BLE Blood Pressure Monitor

K-Number: K212168 · 2022-10-06

Decision Date2022-10-06
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

A&D Medical UM-212BLE Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is A&D Company, Ltd.. It received FDA 510(k) clearance on 2022-10-06 under 510(k) number K212168. 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 A&D Medical UM-212BLE Blood Pressure Monitor?

A&D Medical UM-212BLE Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is A&D Company, Ltd.. The 510(k) number is K212168.

When did A&D Medical UM-212BLE Blood Pressure Monitor receive FDA 510(k) clearance?

A&D Medical UM-212BLE Blood Pressure Monitor received FDA 510(k) clearance on 2022-10-06, under 510(k) number K212168.

Who is the listed applicant for A&D Medical UM-212BLE Blood Pressure Monitor?

The FDA 510(k) record lists A&D Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A&D Medical UM-212BLE Blood Pressure Monitor?

The FDA product code for A&D Medical UM-212BLE Blood Pressure Monitor is DXN.

Other records listing A&D Company, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.