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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name camera, multi format, radiological
510(k) Number K904897
Device Name MODEL 400 ULTRA COMPACT VIDEO IMAGER
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 Number892.2040
Classification Product Code
LMC  
Date Received10/29/1990
Decision Date 11/20/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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