FDA 510(k) Application Details - K080461

Device Classification Name	Monitor, St Segment With Alarm   More FDA Info for this Device
510(K) Number	K080461
Device Name	Monitor, St Segment With Alarm
Applicant	PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. ANDOVER, MA 01810-1099 US Other 510(k) Applications for this Company
Contact	ZETY BILLARD Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MLD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/2008
Decision Date	03/13/2008
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