FDA 510(k)

Arm Blood Pressure Monitor

K-번호: K222869 · 2023-02-15

결정일2023-02-15

제품 코드DXN

자문 위원회CV

결정Substantially Equivalent

기기 요약

Arm Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2023-02-15 under 510(k) number K222869. 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?

Arm Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K222869.

When did Arm Blood Pressure Monitor receive FDA 510(k) clearance?

Arm Blood Pressure Monitor received FDA 510(k) clearance on 2023-02-15, under 510(k) number K222869.

Who is the listed applicant for Arm Blood Pressure Monitor?

The FDA 510(k) record lists Andon Health 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?

The FDA product code for Arm Blood Pressure Monitor is DXN.

Andon Health Co, Ltd.를 신청인으로 등재한 기타 기록

31개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.