FDA 510(k)

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

Numéro K : K222125 · 2022-12-01

DemandeurShenzhen AOJ Medical Technology Co., Ltd.

Date de décision2022-12-01

Code produitDXN

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Source officielle

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