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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 K242528
Device Name Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)
Applicant
Shenzhen Ruiankang Technology Co., Ltd.
Floor1 And 2, #8, Zhugushi Chunyang Industrial Park
Wulian Community, Longgang St., Longgang District
Shenzhen,  CN 518117
Applicant Contact Xinhua Zhao
Correspondent
Shenzhen Ruiankang Technology Co., Ltd.
Floor1 And 2, #8, Zhugushi Chunyang Industrial Park
Wulian Community, Longgang St., Longgang District
Shenzhen,  CN 518117
Correspondent Contact Xinhua Zhao
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/26/2024
Decision Date 01/10/2025
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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