FDA 510(k) Application Details - K111933

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K111933
Device Name	Monitor, Breathing Frequency
Applicant	COVIDIEN 6135 GUNBARREL AVE. BOULDER, CO 80301 US Other 510(k) Applications for this Company
Contact	Jean Simon Other 510(k) Applications for this Contact
Regulation Number	868.2375   More FDA Info for this Regulation Number
Classification Product Code	BZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/08/2011
Decision Date	03/15/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review