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U.S. Department of Health and Human Services

Devices@FDA

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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 PLAZA
20 RAMSEY RD., P.O. BOX 702
shirley,  NY  11967 -0702
Applicant Contact clyde schlein
Correspondent
BIODEX MEDICAL SYSTEMS, INC.
BROOKHAVEN R & D PLAZA
20 RAMSEY RD., P.O. BOX 702
shirley,  NY  11967 -0702
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
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