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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K202372
Device Name Upper Arm Electronic Blood Pressure Monitor
Applicant
Conmo Electronic Company Limited
Room 1402, Building No.10,Shenzhen Biomedicine Innovations
Industrial Park, Jinhui Road No.14,Kengzi Street, Pingshan D
Shenzhen City,  CN 518126
Applicant Contact Alice Qi
Correspondent
International Regulatory Consultants
2950 E Lindrick Drive
Chandler,  AZ  85249
Correspondent Contact Charlie Mack
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/19/2020
Decision Date 12/30/2020
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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