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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 K043359
Device Name 4100 PATIENT OXIMETER MODULE
Applicant
NONIN MEDICAL, INC.
2605 FERNBROOK LANE, NORTH
MINNEAPOLIS,  MN  55447 -4755
Applicant Contact JOHN R DALPEE
Correspondent
NONIN MEDICAL, INC.
2605 FERNBROOK LANE, NORTH
MINNEAPOLIS,  MN  55447 -4755
Correspondent Contact JOHN R DALPEE
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/06/2004
Decision Date 01/07/2005
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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