Med-link Reusable Blood Pressure Cuff

Blood Pressure Cuff

Shenzhen Med-link Electronics Tech Co., Ltd

The following data is part of a premarket notification filed by Shenzhen Med-link Electronics Tech Co., Ltd with the FDA for Med-link Reusable Blood Pressure Cuff.

Pre-market Notification Details

Device IDK173869
510k NumberK173869
Device Name:Med-link Reusable Blood Pressure Cuff
ClassificationBlood Pressure Cuff
Applicant Shenzhen Med-link Electronics Tech Co., Ltd 4th Floor, Building A, Ying Tailong Ind Park Dalang South Road, Longhua Shenzhen,  CN 518109
ContactBaihan Feng
CorrespondentBaihan Feng
Shenzhen Med-link Electronics Tech Co., Ltd 4th Floor, Building A, Ying Tailong Ind Park Dalang South Road, Longhua Shenzhen,  CN 518109
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-20
Decision Date2018-08-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06944414041270 K173869 000
06944414049245 K173869 000
06944414049238 K173869 000
06944414055932 K173869 000

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