510(k) K132320

INTELLIVUE CL RESPIRATION POD by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2014
Date Received
July 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type