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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 Doppler, Ultrasonic
510(k) Number K885155
Device Name MENTOR MDS
Applicant
Imex
6355 Joyce Dr.
Golden,  CO  80403
Applicant Contact ED BISTRICK
Correspondent
Imex
6355 Joyce Dr.
Golden,  CO  80403
Correspondent Contact ED BISTRICK
Regulation Number892.1550
Classification Product Code
IYN  
Date Received12/15/1988
Decision Date 03/14/1989
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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