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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 K113215
Device Name MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
Applicant
NONIN MEDICAL, INC.
13700 1ST AVE, NORTH
Plymouth,  MN  55441
Applicant Contact BRODIE PEDERSON
Correspondent
NONIN MEDICAL, INC.
13700 1ST AVE, NORTH
Plymouth,  MN  55441
Correspondent Contact BRODIE PEDERSON
Regulation Number870.2700
Classification Product Code
MUD  
Date Received11/01/2011
Decision Date 05/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT00939224
Reviewed by Third Party No
Combination Product No
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