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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 K002957
Device Name SOLAR SPO2 MODULE WITH MASIMO SET
Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Applicant Contact DAVID WAHLIG
Correspondent
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Correspondent Contact DAVID WAHLIG
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/22/2000
Decision Date 10/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
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