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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K203620
Device Name Aneroid Sphygmomanometer
Applicant
Wuxi Exanovo Medical Instrument Co., Ltd.
# 42, Xixin Rd., Zhangjing, Xibei Town
Wuxi,  CN 214194
Applicant Contact Xiao Huang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119, Shanghai
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.1120
Classification Product Code
DXQ  
Subsequent Product Code
LDE  
Date Received12/11/2020
Decision Date 03/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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