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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.
No. A102, No. 1 Kesheng Road, Baiyun District
GUangzhou,  CN 510540
Applicant Contact Erika Meng
Correspondent
SGS-CSTC Standards Technical Services Co., Ltd.
108 Kezhu Road
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
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