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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 K230969
Device Name Oxygen Concentrator
Applicant
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
# 36 Danyan Rd.
Danyang,  CN 212300
Applicant Contact Yu Yao
Correspondent
Guangzhou Junyi Information Technology Co., Ltd.
Rm. 215, Huaming Bldg., Chebei Rd.
Guangzhou,  CN 511660
Correspondent Contact Jinghua Zhou
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/05/2023
Decision Date 11/09/2023
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
Recalls CDRH Recalls
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