FDA 510(k)

어깨 혈압 모니터, 모델 AOJ-33A 및 AOJ-33B

K-번호: K222994 · 2023-07-26

신청자Shenzhen AOJ Medical Technology Co., Ltd.

결정일2023-07-26

제품 코드DXN

자문 위원회CV

결정Substantially Equivalent

기기 요약

Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B 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 2023-07-26 under 510(k) number K222994. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B?

Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B is a medical device that received FDA 510(k) clearance on 2023-07-26. The listed applicant is Shenzhen AOJ Medical Technology Co., Ltd.. The 510(k) number is K222994.

When did Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B receive FDA 510(k) clearance?

Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B received FDA 510(k) clearance on 2023-07-26, under 510(k) number K222994.

Who is the listed applicant for Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B?

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-33A and AOJ-33B?

The FDA product code for Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B is DXN.

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