ANDON BLOOD PRESSURE CUFF

Blood Pressure Cuff

ANDON HEALTH CO., LTD

The following data is part of a premarket notification filed by Andon Health Co., Ltd with the FDA for Andon Blood Pressure Cuff.

Pre-market Notification Details

Device IDK133117
510k NumberK133117
Device Name:ANDON BLOOD PRESSURE CUFF
ClassificationBlood Pressure Cuff
Applicant ANDON HEALTH CO., LTD No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT Tianjin,  CN 300190
ContactLiu Yi
CorrespondentLiu Yi
ANDON HEALTH CO., LTD No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT Tianjin,  CN 300190
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-30
Decision Date2014-03-04
Summary:summary

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