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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 K052669
Device Name AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100
Applicant
Nonin Medical, Inc.
13700 1st Ave. N
Plymouth,  MN  55441
Applicant Contact LORI M ROTH
Correspondent
Nonin Medical, Inc.
13700 1st Ave. N
Plymouth,  MN  55441
Correspondent Contact LORI M ROTH
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/27/2005
Decision Date 12/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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