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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nystagmograph
510(k) Number K070729
Device Name BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
Applicant
Fall Prevention Technologies, LLC
4601 Gateway Cir.
Kettering,  OH  45440
Applicant Contact FRANK SCARPINO
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact NEIL E DEVINE
Regulation Number882.1460
Classification Product Code
GWN  
Date Received03/15/2007
Decision Date 03/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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