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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 K250091
Device Name KOROT Blood Pressure Monitor (KOROT P3 Accurate)
Applicant
Korot Co., Ltd.
1-102, 330, Yeongok-Gil, Ipjang-Myeon, Seobuk-Gu, Cheonan-Si
Chungcheongnam-Do
Cheonan,  KR 31026
Applicant Contact Muyeol Lee
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/14/2025
Decision Date 03/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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