FDA 510(k) Application Details - K071889

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K071889
Device Name	Detector And Alarm, Arrhythmia
Applicant	GE HEALTHCARE 86 PILGRIM ROAD NEEDHAM, MA 02492 US Other 510(k) Applications for this Company
Contact	JOEL C KENT Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	DSI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2007
Decision Date	05/19/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review