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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 K231050
Device Name Arm Blood Pressure Monitor
Applicant
Alicn Medical Shenzhen, Inc.
Rm. 410,Bldg. A,3rd Sub-Park,
Leibozhongcheng Life Science Park,Kengzi St.
Shenzhen,  CN 518118
Applicant Contact Fang Meisong
Correspondent
Alicn Medical Shenzhen, Inc.
Rm. 410,Bldg. A,3rd Sub-Park,
Leibozhongcheng Life Science Park,Kengzi St.
Shenzhen,  CN 518118
Correspondent Contact Fang Meisong
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/13/2023
Decision Date 10/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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