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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K132320
Device Name INTELLIVUE CL RESPIRATION POD
Applicant
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Hewlett-Packard St. 2
Boeblingen, Baden-Wuerttemberg,  DE D 71034
Applicant Contact JOHANNES SCHMID
Correspondent
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Hewlett-Packard St. 2
Boeblingen, Baden-Wuerttemberg,  DE D 71034
Correspondent Contact JOHANNES SCHMID
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/25/2013
Decision Date 03/26/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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