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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Platform, Force-Measuring
510(k) Number K942694
FOIA Releasable 510(k) K942694
Device Name STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302
Applicant
Biodex Medical Systems, Inc.
Brookhaven R & D Plz.
20 Ramsey Rd., P.O. Box 702
Shirley,  NY  11967
Applicant Contact CLYDE SCHLEIN
Correspondent
Biodex Medical Systems, Inc.
Brookhaven R & D Plz.
20 Ramsey Rd., P.O. Box 702
Shirley,  NY  11967
Correspondent Contact CLYDE SCHLEIN
Regulation Number890.1575
Classification Product Code
KHX  
Date Received06/07/1994
Decision Date 03/10/1995
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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