FDA 510(k) Application Details - K173869

Device Classification Name Blood Pressure Cuff

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510(K) Number K173869
Device Name Blood Pressure Cuff
Applicant Shenzhen Med-link Electronics Tech Co., Ltd
4th Floor, Building A, Ying Tailong Ind Park
Dalang South Road, Longhua
Shenzhen 518109 CN
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Contact Baihan Feng
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 12/20/2017
Decision Date 08/02/2018
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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