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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K172904
Device Name IntelliVue Capnography Extension, IntelliVue Microstream Extension
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Str.-2
Boeblingen,  DE 71034
Applicant Contact Markus Stacha
Correspondent
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Str.-2
Boeblingen,  DE 71034
Correspondent Contact Markus Stacha
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
BZQ   DRQ   DSA   DXG   FLL  
Date Received09/22/2017
Decision Date 12/26/2017
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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