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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K212385
Device Name YUWELL Finger Pulse Oximeter
Applicant
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Yunyang Industrial Park
Danyang,  CN 212300
Applicant Contact Yuzhuo Wang
Correspondent
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Yunyang Industrial Park
Danyang,  CN 212300
Correspondent Contact Yuzhuo Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/02/2021
Decision Date 08/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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