FDA 510(k) Application Details - K132604

Device Classification Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K132604
Device Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant	COVIDIEN 6135 GUNBARREL AVE. BOULDER, CO 80301 US Other 510(k) Applications for this Company
Contact	KELSEY LEE Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	MWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/2013
Decision Date	12/04/2013
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