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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 K222887
Device Name Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
Applicant
Famidoc Technology Company Limited
#212 Yilong Rd., Hexi Industrial Zone, Jinxia,
Changan Town
Dongguan,  CN 523853
Applicant Contact Amos Zou
Correspondent
Famidoc Technology Company Limited
#212 Yilong Rd., Hexi Industrial Zone, Jinxia,
Changan Town
Dongguan,  CN 523853
Correspondent Contact Amos Zou
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/23/2022
Decision Date 04/10/2023
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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