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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 K834282
Device Name ULTRA IMAGER 2000
Applicant
Honeywell, Inc.
IN 
Correspondent
Honeywell, Inc.
IN 
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/21/1983
Decision Date 04/23/1984
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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