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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 K222658
FOIA Releasable 510(k) K222658
Device Name Accurate 24 Non-invasive blood pressure monitor
Applicant
Accurate Meditech, Inc.
8f-10, # 12, Lane 609, Sec. 5, Chongxin Rd.,
Sanchong Dist.,
New Taipei City,  TW 241406
Applicant Contact Wang Kuan Jen
Correspondent
Herrington Consulting, LLC
No 64, Haijing 3rd St.
Sanzhi District
New Taipei City,  TW 252
Correspondent Contact Douglas Herrington
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/02/2022
Decision Date 06/21/2023
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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