FDA 510(k) Application Details - K173246

Device Classification Name Blood Pressure Cuff

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510(K) Number K173246
Device Name Blood Pressure Cuff
Applicant Wenzhou Bokang Instruments Co., Ltd
No. 1500 Haining Road, Haibin Longwan
Wenzhou 325024 CN
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Contact Youhua Xiang
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 10/06/2017
Decision Date 05/30/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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