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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 K242568
Device Name Wrist Blood Pressure Monitor (OHMS11, OHMS12)
Applicant
Shenzhen Zhongkemingwang Telecommunications Software Corp.
Rm. 1701,T2, Crc Qianhai Center,55, Guiwan 4th Rd. Nanshan
Sub-District, Qianhai Shenzhen-Hong Kong Cooperation Zone
Shenzhen,  CN 518066
Applicant Contact Queena Chen
Correspondent
Shenzhen Zhongkemingwang Telecommunications Software Corp.
Rm. 1701,T2, Crc Qianhai Center,55, Guiwan 4th Rd. Nanshan
Sub-District, Qianhai Shenzhen-Hong Kong Cooperation Zone
Shenzhen,  CN 518066
Correspondent Contact Queena Chen
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/29/2024
Decision Date 01/30/2025
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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