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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter, tissue saturation
510(k) Number K102715
Device Name REGIONAL OXIMETER
Applicant
NONIN MEDICAL, INC.
13700 1ST AVE. NORTH
PLYMOUTH,  MN  55441 -5443
Applicant Contact LORI M MITCHELL
Correspondent
NONIN MEDICAL, INC.
13700 1ST AVE. NORTH
PLYMOUTH,  MN  55441 -5443
Correspondent Contact LORI M MITCHELL
Regulation Number870.2700
Classification Product Code
MUD  
Date Received09/20/2010
Decision Date 12/17/2010
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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