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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 K934908
Device Name FULL VIEW DIGITAL STORAGE SYSTEM
Applicant
International Imaging Electronics
881 Remington Blvd.
Bolingbrook,  IL  60440
Applicant Contact JOHN R MIERS
Correspondent
International Imaging Electronics
881 Remington Blvd.
Bolingbrook,  IL  60440
Correspondent Contact JOHN R MIERS
Regulation Number892.1560
Classification Product Code
IYO  
Date Received10/13/1993
Decision Date 01/28/1994
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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