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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 K202324
Device Name Fingertip Pulse Oximeter
Applicant
Shenzhen BSX Technology Electronics Co., Ltd.
Rm301.3F 8th Building, LiHao Industrial Area,
No.78 AiNan Road, Longgang
Shenzhen,  CN 518116
Applicant Contact Fang Kai
Correspondent
Shenzhen BSX Technology Electronics Co., Ltd.
Rm301.3F 8th Building, LiHao Industrial Area,
No.78 AiNan Road, Longgang
Shenzhen,  CN 518116
Correspondent Contact Fang Kai
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/17/2020
Decision Date 12/14/2020
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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