Aneroid Sphygmomanometer

Blood Pressure Cuff

Jiaxing Zhongfa Medical Products Co., Ltd.

The following data is part of a premarket notification filed by Jiaxing Zhongfa Medical Products Co., Ltd. with the FDA for Aneroid Sphygmomanometer.

Pre-market Notification Details

Device IDK151246
510k NumberK151246
Device Name:Aneroid Sphygmomanometer
ClassificationBlood Pressure Cuff
Applicant Jiaxing Zhongfa Medical Products Co., Ltd. No.38 Building 1, Zhong Fa Group ZhuangShi Village, FengQiao Town, Nanhu Dst Jiaxing,  CN 314008
ContactMao Xiaohua
CorrespondentRay Wang
Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Chaoyang District Beijing,  CN 100024
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-11
Decision Date2015-06-30
Summary:summary

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