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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 K860081
Device Name ESI 2000 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCERS
Applicant
Elscint, Inc.
751 Expy. Dr.
Itasca,  IL  60143
Applicant Contact ROBERT E KENNEY
Correspondent
Elscint, Inc.
751 Expy. Dr.
Itasca,  IL  60143
Correspondent Contact ROBERT E KENNEY
Regulation Number892.1560
Classification Product Code
IYO  
Date Received01/08/1986
Decision Date 06/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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