FDA 510(k) Application Details - K061994

Device Classification Name	System,Network And Communication,Physiological Monitors   More FDA Info for this Device
510(K) Number	K061994
Device Name	System,Network And Communication,Physiological Monitors
Applicant	GE HEALTHCARE 86 PILGRIM ROAD NEEDHAM, MA 02492 US Other 510(k) Applications for this Company
Contact	JOEL KENT Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	MSX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2006
Decision Date	08/11/2006
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