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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 K052582
Device Name DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES
Applicant
GE Healthcare
86 Pilgrim Rd.
Needham,  MA  02492
Applicant Contact JOEL KENT
Correspondent
GE Healthcare
86 Pilgrim Rd.
Needham,  MA  02492
Correspondent Contact JOEL KENT
Regulation Number868.1400
Classification Product Code
CCK  
Date Received09/20/2005
Decision Date 10/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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