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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 Doppler, Ultrasonic
510(k) Number K211665
Device Name SONON Ultrasound Imaging System, Model: SONON300C
Applicant
Healcerion Co., Ltd.
1403-Ho, 12, Digital-Ro 33-Gil, Guro-Gu
Seoul,  KR 08377
Applicant Contact Lee Sooyeol
Correspondent
Gms Consulting Co., Ltd.
34, Sangamsan-Ro, Mapo-Gu
Seoul,  KR 03909
Correspondent Contact Jong Hyun Kim
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received06/01/2021
Decision Date 05/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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