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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 K241671
Device Name 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
Applicant
Esaote S.p.A.
via Enrico Melen 77
Genoa,  IT 16152
Applicant Contact Alberto Carcagnì
Correspondent
Esaote S.p.A.
via Enrico Melen 77
Genoa,  IT 16152
Correspondent Contact Vanessa Ronconi
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   QIH  
Date Received06/11/2024
Decision Date 05/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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