FDA 510(k)

Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G

K-Number: K222125 · 2022-12-01

ApplicantShenzhen AOJ Medical Technology Co., Ltd.

Decision Date2022-12-01

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen AOJ Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-01 under 510(k) number K222125. 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 Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G?

Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G is a medical device that received FDA 510(k) clearance on 2022-12-01. The listed applicant is Shenzhen AOJ Medical Technology Co., Ltd.. The 510(k) number is K222125.

When did Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G receive FDA 510(k) clearance?

Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G received FDA 510(k) clearance on 2022-12-01, under 510(k) number K222125.

Who is the listed applicant for Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G?

The FDA 510(k) record lists Shenzhen AOJ Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G?

The FDA product code for Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G is DXN.

Other records listing Shenzhen AOJ Medical Technology Co., 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.

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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.