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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K031487
Device Name MODEL AVANT 2120 PULSE OXIMETER AND NIBP
Applicant
NONIN MEDICAL, INC.
2605 FERNBROOK LANE, NORTH
MINNEAPOLIS,  MN  55447 -4755
Applicant Contact RICHARD P BENNETT
Correspondent
NONIN MEDICAL, INC.
2605 FERNBROOK LANE, NORTH
MINNEAPOLIS,  MN  55447 -4755
Correspondent Contact RICHARD P BENNETT
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/12/2003
Decision Date 03/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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