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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 K041156
Device Name AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001
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 Received05/03/2004
Decision Date 06/09/2004
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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