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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K260251
Device Name BreathCare PAP III (YH-390N)
Applicant
Suzhou Yuyue Medical Technology Co., Ltd.
#9 Jinfeng Rd., Suzhou Science & Technology Town
Suzhou,  CN 215163
Applicant Contact Fang Zhang
Correspondent
Suzhou Yuyue Medical Technology Co., Ltd.
#9 Jinfeng Rd., Suzhou Science & Technology Town
Suzhou,  CN 215163
Correspondent Contact Fang Zhang
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/27/2026
Decision Date 10/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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