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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 K860821
Device Name BIODEX SYSTEM
Applicant
Biodex Corp.
32 Chichester Ave.
P.O. Box 656
Center Moriches,  NY  11934
Applicant Contact JAMES REISS
Correspondent
Biodex Corp.
32 Chichester Ave.
P.O. Box 656
Center Moriches,  NY  11934
Correspondent Contact JAMES REISS
Regulation Number890.1925
Classification Product Code
IKK  
Date Received03/04/1986
Decision Date 04/18/1986
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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