Reusable Blood Pressure Cuff

Blood Pressure Cuff

Shenzhen Vistar Medical Supplies Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Vistar Medical Supplies Co., Ltd. with the FDA for Reusable Blood Pressure Cuff.

Pre-market Notification Details

Device IDK152468
510k NumberK152468
Device Name:Reusable Blood Pressure Cuff
ClassificationBlood Pressure Cuff
Applicant Shenzhen Vistar Medical Supplies Co., Ltd. 808, Hanhaida Bldg., No. 7 Songgang Blvd. Songgang Town Shenzhen,  CN 518105
ContactZhenxun Chen
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 Received2015-08-31
Decision Date2015-10-29
Summary:summary

NIH GUDID Devices

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