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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 K161354
FOIA Releasable 510(k) K161354
Device Name MELODY, Remote Control System for Ultrasound Probe
Applicant
Adecho Tech
7 Rue Du Clos Haut De La Bouchardiere
Naveil,  FR 41100
Applicant Contact Nicolas LEFEBVRE
Correspondent
Benjamin L. England & Associates, LLC
810 Landmark Dr. Suite 126
Glen Burnie,  MD  21061
Correspondent Contact Thomas C. Knott
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received05/16/2016
Decision Date 06/12/2017
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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