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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Sonometer
510(k) Number K180516
Device Name EchoS
Applicant
Echolight S.P.A
Via Raffaello Sanzio, 18
Lecce,  IT 73100
Applicant Contact Sergio Casciaro
Correspondent
Isemed S.R.L.
Via P. Togliatti, 19/X
Imola,  IT 40026
Correspondent Contact Maurizio Pantaleoni
Regulation Number892.1180
Classification Product Code
MUA  
Date Received02/27/2018
Decision Date 10/19/2018
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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