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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 K053419
Device Name KONICA MINOLTA PULSOX-300, 300I
Applicant
KONICA MINOLTA SENSING, INC.
2703 JOSEPHINE ST.
DENVER,  CO  80205
Applicant Contact NANCI DEXTER
Correspondent
KONICA MINOLTA SENSING, INC.
2703 JOSEPHINE ST.
DENVER,  CO  80205
Correspondent Contact NANCI DEXTER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/08/2005
Decision Date 05/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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