Aneroid Sphygmomanometer With Stethoscope, QL-50, Aneroid Sphygmomanometer, QL-20, Aneroid Sphygmomanometer, QL-201

Blood Pressure Cuff

Zhejiang LuDe Technology Development Co., Ltd.

The following data is part of a premarket notification filed by Zhejiang Lude Technology Development Co., Ltd. with the FDA for Aneroid Sphygmomanometer With Stethoscope, Ql-50, Aneroid Sphygmomanometer, Ql-20, Aneroid Sphygmomanometer, Ql-201.

Pre-market Notification Details

Device IDK221857
510k NumberK221857
Device Name:Aneroid Sphygmomanometer With Stethoscope, QL-50, Aneroid Sphygmomanometer, QL-20, Aneroid Sphygmomanometer, QL-201
ClassificationBlood Pressure Cuff
Applicant Zhejiang LuDe Technology Development Co., Ltd. NO. 298 Jichang North Road, Longwan District Wenzhou,  CN 325024
ContactIris Du
CorrespondentIris Du
Zhejiang LuDe Technology Development Co., Ltd. NO. 298 Jichang North Road, Longwan District Wenzhou,  CN 325024
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-27
Decision Date2022-10-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10010939960181 K221857 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.