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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 K221486
Device Name INDEX BPM
Applicant
Ya Horng Electronic Co., Ltd.
#35, Shalun, Anding Dist.
Taiwan,  TW 745
Applicant Contact Jerry Hsu
Correspondent
Ya Horng Electronic Co., Ltd.
#35, Shalun, Anding Dist.
Taiwan,  TW 745
Correspondent Contact Jerry Hsu
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/23/2022
Decision Date 08/30/2022
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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