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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, West zone, No.1 Building, No.7 Yard,
Fengxian middle Road, HaiDian District
Beijing,  CN 100094
Applicant Contact Calen Chen
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North 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
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