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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 K223740
Device Name Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
Applicant
Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.
#8, Shengchang W. Rd.,
Danyang Economy Development Zone Danyang, Jiangsu, China
Jiangsu,  CN 212300
Applicant Contact Heidi Zhang
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plaza,
Shuixi Rd., Huangpu District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/14/2022
Decision Date 10/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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