Aneroid Sphygmomanometer

Blood Pressure Cuff

Wuxi Exanovo Medical Instrument Co., Ltd.

The following data is part of a premarket notification filed by Wuxi Exanovo Medical Instrument Co., Ltd. with the FDA for Aneroid Sphygmomanometer.

Pre-market Notification Details

Device IDK203620
510k NumberK203620
Device Name:Aneroid Sphygmomanometer
ClassificationBlood Pressure Cuff
Applicant Wuxi Exanovo Medical Instrument Co., Ltd. No. 42, Xixin Road, Zhangjing, Xibei Town Wuxi,  CN 214194
ContactXiao Huang
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-11
Decision Date2021-03-23


Device IdentifiersubmissionNumberSupplement
06970691000068 K203620 000
06970691000211 K203620 000
06970691000228 K203620 000
06970691000235 K203620 000
06970691000242 K203620 000
06970691000259 K203620 000
06970691000266 K203620 000
06970691000037 K203620 000
06970691000044 K203620 000
06970691000051 K203620 000
06970691000273 K203620 000

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