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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
Models 865218, 866009, 989803179541, M3002A,M8102A,M8105A,M8105AT,AND M8105AS
Device Name NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO
Original Applicant
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
hewlett-packard str. 2
boeblingen,  GM 71034
Original Contact markus stacha
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/25/2012
Decision Date 04/12/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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