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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 K052880
Device Name DATEX-OHMEDA S/5 INTERFACE MODULE E-INT
Applicant
GE HEALTHCARE
86 PILGRIM ROAD
NEEDHAM,  MA  02492
Applicant Contact JOEL C KENT
Correspondent
GE HEALTHCARE
86 PILGRIM ROAD
NEEDHAM,  MA  02492
Correspondent Contact JOEL C KENT
Regulation Number868.1400
Classification Product Code
CCK  
Date Received10/12/2005
Decision Date 11/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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