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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 K192157
Device Name 6450 Ultrasound system
Applicant
Esaote, S.p.A.
Via E Melen 77
Genoa,  IT 16152
Applicant Contact Piet DeJong
Correspondent
Esaote, S.p.A.
Via E Melen 77
Genoa,  IT 16152
Correspondent Contact Piet DeJong
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/09/2019
Decision Date 11/22/2019
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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