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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 K191072
Device Name 7410 Ultrasound System (MyLabSigma)
Applicant
Esaote, S.P.A.
Via Enrico Melen 77
Genoa,  IT 16152
Applicant Contact Piet De Jong
Correspondent
Esaote, S.P.A.
Via Enrico Melen 77
Genoa,  IT 16152
Correspondent Contact Piet De Jong
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/22/2019
Decision Date 06/10/2019
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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