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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 K191875
Device Name Owgels Oxygen Concentrator
Applicant
Guangzhou Life Light Electronic Technology Co., Ltd.
# A102, # 1 Kesheng Rd., Baiyun District
Guangzhou,  CN 510540
Applicant Contact Erika Meng
Correspondent
Sgs-Cstc Standards Technical Services Co., Ltd.
108 Kezhu Rd.
Scientech Park Guangzhou Economic & Technology
Guangzhou,  CN 510060
Correspondent Contact Iris Fung
Regulation Number868.5440
Classification Product Code
CAW  
Date Received07/12/2019
Decision Date 07/20/2020
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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