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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ballistocardiograph
510(k) Number K081603
Device Name DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
Applicant
Heartforce Medical, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
Heartforce Medical, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Correspondent Contact ARTHUR WARD
Regulation Number870.2320
Classification Product Code
DXR  
Date Received06/06/2008
Decision Date 07/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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