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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 K122223
Device Name NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard St. 2
Boeblingen,  DE 71034
Applicant Contact MARKUS STACHA
Correspondent
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard St. 2
Boeblingen,  DE 71034
Correspondent Contact MARKUS STACHA
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/25/2012
Decision Date 04/12/2013
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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