FDA 510(k) Application Details - K233799

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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510(K) Number K233799
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant Shenzhen Yuezhongxing Technology Co., Ltd.
No.2, Zhenye Road, Liulian Community, Pingshan Avenue
Pingshan District
Shenzhen 518015 CN
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Contact Yuchao Chen
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 11/29/2023
Decision Date 03/15/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233799


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