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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 K161168
Device Name MyLabSix Ultrasound System
Applicant
Esaote Europe B.V.
Philipsweg 1
Maastricht,  NL 6227 AJ
Applicant Contact Bert Vorstenbosch
Correspondent
Navigant Consulting, Inc.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Correspondent Contact Allison Scott
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/26/2016
Decision Date 09/02/2016
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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