FDA 510(k) Application Details - K173044

Device Classification Name Blood Pressure Cuff

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510(K) Number K173044
Device Name Blood Pressure Cuff
Applicant Ningbo Albert Novosino Co.,Ltd.
No.1 Xinheng 3 Road Cicheng Town
Jiangbei District
Ningbo 315036 CN
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Contact Ningbo Albert Novosino
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 09/28/2017
Decision Date 11/20/2017
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 K173044


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