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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 K142687
Device Name Pulse Oximeter
Applicant
Shanghai Berry Electronic Tech Co., Ltd
Unit C, 1st Floor, 7th Building, No. 1188 Lianhang Road
Shanghai,  CN
Applicant Contact Xuezhi Yin
Correspondent
Beijing Believe Tech. Service Co., Ltd.
1-202, Build 3, Beijing New World, No.5 Chaoyang Rd.,
Beijing,  CN
Correspondent Contact Ray Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/22/2014
Decision Date 04/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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