FDA 510(k) Application Details - K231961

Device Classification Name Blood Pressure Cuff

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510(K) Number K231961
Device Name Blood Pressure Cuff
Applicant Shenzhen SINO-K Medical Technology Co.,Ltd
Room401,Bldg2,Veteran Ind.city,Gonglc Community
xixiang Strcct,Baoan District
Shenzhen 518115 CN
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Contact Lao Chengxin
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 07/03/2023
Decision Date 08/30/2023
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



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