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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 K250837
Device Name Pulse Oximeter
Applicant
Shanghai Berry Electronic Tech Co., Ltd.
Unit 104, 1st Floor, 7th Bldg., #118 Lianhang Rd.,
Minhang District
Shanghai,  CN 201112
Applicant Contact Xu Yan
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lujiazui Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/20/2025
Decision Date 09/25/2025
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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