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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, Oxygen, Gaseous-Phase
510(k) Number K051092
Device Name DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC
Applicant
GE Healthcare
86 Pilgrim Rd.
Needham,  MA  02492
Applicant Contact JOEL C KENT
Correspondent
GE Healthcare
86 Pilgrim Rd.
Needham,  MA  02492
Correspondent Contact JOEL C KENT
Regulation Number868.1720
Classification Product Code
CCL  
Subsequent Product Codes
BZK   BZL   CAP   CBQ   CBR  
CBS   NHO   NHP   NHQ  
Date Received04/28/2005
Decision Date 05/25/2005
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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