FDA 510(k)

YUWELL Finger Pulse Oximeter

K-번호: K212385 · 2022-08-16

신청자Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

결정일2022-08-16

제품 코드DQA

자문 위원회CV

결정Substantially Equivalent

기기 요약

YUWELL Finger Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2022-08-16 under 510(k) number K212385. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the YUWELL Finger Pulse Oximeter?

YUWELL Finger Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2022-08-16. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K212385.

When did YUWELL Finger Pulse Oximeter receive FDA 510(k) clearance?

YUWELL Finger Pulse Oximeter received FDA 510(k) clearance on 2022-08-16, under 510(k) number K212385.

Who is the listed applicant for YUWELL Finger Pulse Oximeter?

The FDA 510(k) record lists Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YUWELL Finger Pulse Oximeter?

The FDA product code for YUWELL Finger Pulse Oximeter is DQA.

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.를 신청인으로 등재한 기타 기록

K261571Manual Wheelchair (H008, PCK7)K252779YUWELL® Electronic Blood Pressure Monitor (YE630CR)K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)K242736Portable Oxygen Concentrator (Spirit-3)K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)

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