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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K231677
Device Name EdgeFlow UH10
Applicant
Edgecare Inc.
403, Teihard Hall, 35, Baekbeom-ro, Mapo-gu
Seoul,  KR 04107
Applicant Contact Park Sangeun
Correspondent
KMC, Inc.
Room no. 1709, 123, Digital-ro 26-gil, Guro-gu
Seoul,  KR 08390
Correspondent Contact Milly .
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   QIH  
Date Received06/09/2023
Decision Date 03/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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