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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K052755
Device Name DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT
Applicant
GE HEALTHCARE
86 pilgrim road
needham,  MA  02492
Applicant Contact joel kent
Correspondent
GE HEALTHCARE
86 pilgrim road
needham,  MA  02492
Correspodent Contact joel kent
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received09/30/2005
Decision Date 10/13/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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