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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Isokinetic Testing And Evaluation
510(k) Number K901566
Device Name PROMATRON 3000
Applicant
Promatek Medical Systems, Inc.
1851 Black Rd.
Joliet,  IL  60435
Applicant Contact HELENE LITCHFIELD
Correspondent
Promatek Medical Systems, Inc.
1851 Black Rd.
Joliet,  IL  60435
Correspondent Contact HELENE LITCHFIELD
Regulation Number890.1925
Classification Product Code
IKK  
Date Received04/03/1990
Decision Date 10/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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