FDA 510(k)

Full Automatic (NIBP) Blood Pressure Monitor

K-번호: K162338 · 2016-09-21

결정일2016-09-21

제품 코드DXN

자문 위원회CV

결정Substantially Equivalent

기기 요약

Full Automatic (NIBP) Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Health & Life Co., Ltd.. It received FDA 510(k) clearance on 2016-09-21 under 510(k) number K162338. 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 Full Automatic (NIBP) Blood Pressure Monitor?

Full Automatic (NIBP) Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K162338.

When did Full Automatic (NIBP) Blood Pressure Monitor receive FDA 510(k) clearance?

Full Automatic (NIBP) Blood Pressure Monitor received FDA 510(k) clearance on 2016-09-21, under 510(k) number K162338.

Who is the listed applicant for Full Automatic (NIBP) Blood Pressure Monitor?

The FDA 510(k) record lists Health & Life Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Full Automatic (NIBP) Blood Pressure Monitor?

The FDA product code for Full Automatic (NIBP) Blood Pressure Monitor is DXN.

Health & Life Co., Ltd.를 신청인으로 등재한 기타 기록

K211744Non-Contact Infrared Thermometer, model HL710H K211127Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM K200521Full Automatic(NIBP) Blood Pressure Monitor K190507Full Automatic (NIBP) Blood Pressure Monitor K190133Full Automatic (NIBP) Blood Pressure Monitor-HL158UB K190134Full Automatic (NIBP) Blood Pressure Monitor-HL158TB

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