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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 K222370
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 Calen Chen
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui
#5, Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number870.2900
Classification Product Code
DSA  
Date Received08/05/2022
Decision Date 04/02/2023
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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