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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 K222920
Device Name Oxygen concentrator
Applicant
Zhengzhou Olive Electronic Technology Co., Ltd.
5th Floor, Block D, Bldg. 18,
Henan International University Science Park (East District)
Zhenghou,  CN 450001
Applicant Contact Yunping Qu
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lujiazui Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/26/2022
Decision Date 07/20/2023
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
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