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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 K230179
Device Name 6440 MyLabX90
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   QIH  
Date Received01/23/2023
Decision Date 11/29/2023
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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