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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 K161359
Device Name 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
Applicant
Esaote S.p.A
Via A. Siffredi 58
Genova,  IT 16153
Applicant Contact Massimo Polignano
Correspondent
Navigant Consulting, Inc
9001 Wesleyan Road, Suite 200
Indianapolis,  IN  46268
Correspondent Contact Allison Scott
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/16/2016
Decision Date 07/19/2016
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
Recalls CDRH Recalls
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