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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 K223830
Device Name Ultrasound System 2300
Applicant
BK Medical Aps
Mileparken 34
Herlev,  DK 2730
Applicant Contact Inesa Cernajute
Correspondent
BK Medical Aps
Mileparken 34
Herlev,  DK 2730
Correspondent Contact Inesa Cernajute
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/21/2022
Decision Date 04/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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