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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 K013319
Device Name NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
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 Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DXN  
Date Received10/05/2001
Decision Date 01/03/2002
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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