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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 K252805
Device Name YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
Applicant
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
#1 Baisheng Rd. Development Zone
Danyang,  CN 212300
Applicant Contact Fang (Fawn) Zhang
Correspondent
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
#1 Baisheng Rd. Development Zone
Danyang,  CN 212300
Correspondent Contact Fang (Fawn) Zhang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/03/2025
Decision Date 02/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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