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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 K190447
Device Name 7400 Ultrasound Systems
Applicant
Navigant Consulting - on Behalf of Esaote S.P.A.
9100 Keystone Crossing Suite 500
Indianapolis,  IN  46240
Applicant Contact Allison Scott
Correspondent
Navigant Consulting - on Behalf of Esaote S.P.A.
9100 Keystone Crossing Suite 500
Indianapolis,  IN  46240
Correspondent Contact Allison Scott
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received02/25/2019
Decision Date 04/01/2019
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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