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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 K901071
Device Name PULSE OXIMETRY MODULE
Applicant
MARQUETTE ELECTRONICS, INC.
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Applicant Contact SANDRA L SCHICK
Correspondent
MARQUETTE ELECTRONICS, INC.
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Correspondent Contact SANDRA L SCHICK
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/07/1990
Decision Date 06/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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