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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 STR.2
BOEBLINGEN,  DE D 71034
Applicant Contact JOHANNES SCHMID
Correspondent
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
HEWLETT-PACKARD STR.2
BOEBLINGEN,  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
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