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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 K980299
Device Name APEX OXIMETER
Applicant
MARQUETTE MEDICAL SYSTEMS, INC.
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Applicant Contact DAVID WAHLIG
Correspondent
MARQUETTE MEDICAL SYSTEMS, INC.
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Correspondent Contact DAVID WAHLIG
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/27/1998
Decision Date 04/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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