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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 K010413
Device Name MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
Applicant
Konica Minolta Sensing, Inc.
458 S. Random Rd.
Bailey,  CO  80421
Applicant Contact NANCI DEXTER
Correspondent
Konica Minolta Sensing, Inc.
458 S. Random Rd.
Bailey,  CO  80421
Correspondent Contact NANCI DEXTER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/12/2001
Decision Date 08/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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