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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 K951771
Device Name COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM
Applicant
Sms Technologies, Ltd.
Elizabeth House
Elizabeth Way
Harlow, Essex,  GB CM19 5TL
Applicant Contact ALAN WENMAN
Correspondent
Sms Technologies, Ltd.
Elizabeth House
Elizabeth Way
Harlow, Essex,  GB CM19 5TL
Correspondent Contact ALAN WENMAN
Regulation Number890.1575
Classification Product Code
KHX  
Date Received04/17/1995
Decision Date 08/11/1995
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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