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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 K202514
Device Name EchoS Family
Applicant
Echolight S.P.A
Via Raffaello Sanzio, 18
Lecce,  IT 73100
Applicant Contact Giovanna De Masi
Correspondent
Echolight S.P.A
Via Raffaello Sanzio, 18
Lecce,  IT 73100
Correspondent Contact Giovanna De Masi
Regulation Number892.1180
Classification Product Code
MUA  
Subsequent Product Code
OMV  
Date Received08/31/2020
Decision Date 02/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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