FDA 510(k) Application Details - K242721

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

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510(K) Number K242721
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant Shenzhen Finicare Co., Ltd.
201, No.50, the 3rd Industrial Park, Houting Community
Shajing Street, Bao'an District
Shenzhen 518104 CN
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Contact Li Chao
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 09/10/2024
Decision Date 10/04/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242721


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