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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 K920373
Device Name MAESTRO DIGITAL VIDEO SYSTEM
Applicant
International Imaging Electronics
901 S. Kay
Addison,  IL  60101
Applicant Contact JOHN MIERS
Correspondent
International Imaging Electronics
901 S. Kay
Addison,  IL  60101
Correspondent Contact JOHN MIERS
Regulation Number892.1560
Classification Product Code
IYO  
Date Received01/29/1992
Decision Date 06/24/1992
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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