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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 K212021
Device Name 6430 MyLabX75, 6430 MyLab XPro75
Applicant
Esaote S.p.A.
Via Enrico Melen 77
Genoa,  IT 16152
Applicant Contact Alberto Carcagni
Correspondent
Esaote S.p.A.
Via Enrico Melen 77
Genoa,  IT 16152
Correspondent Contact Alberto Carcagni
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received06/28/2021
Decision Date 09/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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