Aneroid Type Blood Pressure Kit

Blood Pressure Cuff

Dongguan Mars Medical Products Co., Ltd

The following data is part of a premarket notification filed by Dongguan Mars Medical Products Co., Ltd with the FDA for Aneroid Type Blood Pressure Kit.

Pre-market Notification Details

Device IDK191209
510k NumberK191209
Device Name:Aneroid Type Blood Pressure Kit
ClassificationBlood Pressure Cuff
Applicant Dongguan Mars Medical Products Co., Ltd 381, Manfeng West Road, Manfeng Group Dani Village, Shatian Town, Dongguan Cit,  CN 523993
ContactLily Liao
CorrespondentJinghua Zhou
Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou,  CN 511660
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-06
Decision Date2019-06-18

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