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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 Echo, Ultrasonic
510(k) Number K212851
Device Name EchoSK and EchoSGyn modules for EchoS Family devices
Applicant
Echolight S.P.A
Via Raffaello Sanzio, 18
Lecce,  IT 73100
Applicant Contact Giuseppe Criscenti
Correspondent
Echolight S.P.A
Via Raffaello Sanzio, 18
Lecce,  IT 73100
Correspondent Contact Giuseppe Criscenti
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
MUA  
Date Received09/07/2021
Decision Date 03/16/2022
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
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