FDA 510(k) Application Details - K081603

Device Classification Name	Ballistocardiograph   More FDA Info for this Device
510(K) Number	K081603
Device Name	Ballistocardiograph
Applicant	HEARTFORCE MEDICAL, INC. 962 ALLEGRO LANE APOLLO BEACH, FL 33572 US Other 510(k) Applications for this Company
Contact	ARTHUR WARD Other 510(k) Applications for this Contact
Regulation Number	870.2320   More FDA Info for this Regulation Number
Classification Product Code	DXR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2008
Decision Date	07/24/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review