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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 K093853
Device Name SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES
Applicant
NONIN MEDICAL, INC.
13700 1ST AVE. NORTH
PLYMOUTH,  MN  55441 -5443
Applicant Contact LORI ROTH
Correspondent
NONIN MEDICAL, INC.
13700 1ST AVE. NORTH
PLYMOUTH,  MN  55441 -5443
Correspondent Contact LORI ROTH
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/16/2009
Decision Date 06/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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