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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K242986
Device Name SpO2 Extension Cable
Applicant
Beijing Rongrui-Century Science & Technology Co., Ltd.
3rd Floor, W. Zone, #1 Bldg., #7 Yard,
Fengxian Middle Rd., Haidian District
Beijing,  CN 100094
Applicant Contact Zhenghua Zhang
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui, #5,
Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Wang Ray
Regulation Number870.2900
Classification Product Code
DSA  
Subsequent Product Code
DQA  
Date Received09/26/2024
Decision Date 05/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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