FDA 510(k) Application Details - K152468

Device Classification Name Blood Pressure Cuff

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510(K) Number K152468
Device Name Blood Pressure Cuff
Applicant Shenzhen Vistar Medical Supplies Co., Ltd.
808, Hanhaida Bldg., No. 7 Songgang Blvd.
Songgang Town
Shenzhen 518105 CN
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Contact Zhenxun Chen
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 08/31/2015
Decision Date 10/29/2015
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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