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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K172141
Device Name Pulse Oximeter
Applicant
Shanghai Berry Electronic Tech Co., Ltd
Unit C, 1st Floor, 7th Building, No. 1188 Lianhang Road
Minhang District,
Shanghai,  CN 201112
Applicant Contact Xuezhi Yin
Correspondent
Beijing Believe Technology Service Co., Ltd.
5-402, Building #27, No. 56, LiangXiang East Rd.,
FangShan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/17/2017
Decision Date 04/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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