FDA 510(k) Application Details - K232772

Device Classification Name Blood Pressure Cuff

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510(K) Number K232772
Device Name Blood Pressure Cuff
Applicant Shenzhen Plinma Technology Co. Ltd.
401, Xinheng Building No.22, Row 3, Shiling Road
Jinsha Community, Kengzi Street, Pingshan District
Shenzhen 518122 CN
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Contact Zhang Mongdi
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 09/11/2023
Decision Date 11/29/2023
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

FDA Source Information for K232772


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