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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 K253109
Device Name Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)
Applicant
Shenzhen Best Electronics Co., Ltd.
605 # 59 Bldg., The Second Industrial
Zone, Tianliao Community, Yutang St., Guangming District
Shenzhen,  CN
Applicant Contact Martin Wong
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq.
Liuxian Ave., Xili Town, Nanshan District
Shenzhen,  CN 518100
Correspondent Contact Lucy Yan
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/24/2025
Decision Date 01/07/2026
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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