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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K242736
Device Name Portable Oxygen Concentrator (Spirit-3)
Applicant
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
#1 Baisheng Rd. Development Zone
Danyang,  CN 212300
Applicant Contact Yan Wei
Correspondent
Qimmiq Medical Consulting Service Co., Ltd.
Rm.406, Bldg. C, Run Science Park
#18 Shenzhou Rd., Huangpu
Guangzhou,  CN 510663
Correspondent Contact Yijie You
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/11/2024
Decision Date 06/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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