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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 K870964
Device Name ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCER
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 Received03/10/1987
Decision Date 03/13/1987
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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