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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Contrast Medium, Automatic
510(k) Number K984058
Device Name ACIST INJECTOR SYSTEM, MODEL CL100 H
Applicant
Acist Medical Systems
10250 Valley View Rd., #117
Eden Prairie,  MN  55344
Applicant Contact KATE ANDERSON
Correspondent
Acist Medical Systems
10250 Valley View Rd., #117
Eden Prairie,  MN  55344
Correspondent Contact KATE ANDERSON
Regulation Number870.1650
Classification Product Code
IZQ  
Date Received11/13/1998
Decision Date 02/11/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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