FDA 510(k)

어깨 혈압 모니터/자동 무선 스마트 혈압 모니터

K-번호: K222887 · 2023-04-10

결정일2023-04-10

제품 코드DXN

자문 위원회CV

결정Substantially Equivalent

기기 요약

Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Famidoc Technology Company Limited. It received FDA 510(k) clearance on 2023-04-10 under 510(k) number K222887. 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/Automatic Wireless Smart Blood Pressure Monitor?

Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2023-04-10. The listed applicant is Famidoc Technology Company Limited. The 510(k) number is K222887.

When did Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor receive FDA 510(k) clearance?

Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor received FDA 510(k) clearance on 2023-04-10, under 510(k) number K222887.

Who is the listed applicant for Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor?

The FDA 510(k) record lists Famidoc Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor?

The FDA product code for Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor is DXN.

Famidoc Technology Company Limited를 신청인으로 등재한 기타 기록

K233192Wireless Smart Thermometer K191673Upper Arm Blood Pressure Monitor

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