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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 K081870
Device Name MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO
Applicant
GE HEALTHCARE FINLAND OY
8200 WEST TOWER AVENUE
MILWAUKEE,  WI  53223
Applicant Contact JOHN PENDERGAST
Correspondent
GE HEALTHCARE FINLAND OY
8200 WEST TOWER AVENUE
MILWAUKEE,  WI  53223
Correspondent Contact JOHN PENDERGAST
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/01/2008
Decision Date 07/31/2008
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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