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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Carbon-Dioxide, Cutaneous
510(k) Number K110474
Device Name PHILIPS INTELLIVUE TCG10
Applicant
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Hewlett-Packard St. 2
Boeblingen, Baden-Wuerttemberg,  DE D 71034
Applicant Contact JENS-PETER SEHER
Correspondent
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Hewlett-Packard St. 2
Boeblingen, Baden-Wuerttemberg,  DE D 71034
Correspondent Contact JENS-PETER SEHER
Regulation Number868.2480
Classification Product Code
LKD  
Subsequent Product Codes
KLK   LPP  
Date Received02/18/2011
Decision Date 09/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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