FDA 510(k) Application Details - K222370

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

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510(K) Number K222370
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 Calen Chen
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 08/05/2022
Decision Date 04/02/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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