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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 K203347
Device Name Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask
Applicant
Suzhou Yuyue Medical Technology Co., Ltd.
No. 9 Jinfeng Road, Suzhou Science & Technology Town
Suzhou,  CN 215163
Applicant Contact Sun Wei
Correspondent
Suzhou Yuyue Medical Technology Co., Ltd.
No. 9 Jinfeng Road, Suzhou Science & Technology Town
Suzhou,  CN 215163
Correspondent Contact Sun Wei
Regulation Number868.5905
Classification Product Code
BZD  
Date Received11/13/2020
Decision Date 07/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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