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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 K900741
Device Name BIODEX BACK SYSTEM ATTACHMENT
Applicant
Biodex Corp.
20 Ramsay Rd.
P.O. Box 702
Shirley,  NY  11967
Applicant Contact JAMES REISS
Correspondent
Biodex Corp.
20 Ramsay Rd.
P.O. Box 702
Shirley,  NY  11967
Correspondent Contact JAMES REISS
Regulation Number890.1925
Classification Product Code
IKK  
Date Received02/16/1990
Decision Date 02/26/1990
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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