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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Fetal
510(k) Number K901593
Device Name IMEX DOP-TONE II
Applicant
Imex Medical Systems, Inc.
6355 Joyce Dr.
Golden,  CO  80403
Applicant Contact ED BISTRICK
Correspondent
Imex Medical Systems, Inc.
6355 Joyce Dr.
Golden,  CO  80403
Correspondent Contact ED BISTRICK
Regulation Number884.2660
Classification Product Code
KNG  
Date Received04/05/1990
Decision Date 07/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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