FDA 510(k) Application Details - K071228

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K071228
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	SIGNALIFE, INC. 531 SOUTH MAIN ST. SUITE 301 GREENVILLE, SC 29601 US Other 510(k) Applications for this Company
Contact	WILLIAM MATTHEWS Other 510(k) Applications for this Contact
Regulation Number	870.2920   More FDA Info for this Regulation Number
Classification Product Code	DXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2007
Decision Date	11/21/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review