Reusable NIBP Cuff

Blood Pressure Cuff

Shenzhen Coreray Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Coreray Technology Co., Ltd. with the FDA for Reusable Nibp Cuff.

Pre-market Notification Details

Device IDK211747
510k NumberK211747
Device Name:Reusable NIBP Cuff
ClassificationBlood Pressure Cuff
Applicant Shenzhen Coreray Technology Co., Ltd. Floor 5, Building 10, Huangbeiling Jingxuan Industrial Park Yousong Community, Longhua District Shenzhen,  CN 518109
ContactSimon Fan
CorrespondentSimon Fan
Shenzhen Coreray Technology Co., Ltd. Floor 5, Building 10, Huangbeiling Jingxuan Industrial Park Yousong Community, Longhua District Shenzhen,  CN 518109
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-07
Decision Date2021-09-23

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