FDA 510(k) Application Details - K242986

Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)

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510(K) Number K242986
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant Beijing Rongrui-Century Science & Technology Co., Ltd.
3rd Floor, West zone, No.1 Building, No.7 Yard,
Fengxian middle Road, HaiDian District
Beijing 100094 CN
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Contact Zhenghua Zhang
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 09/26/2024
Decision Date 05/02/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242986


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