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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 K051107
Device Name ONYX II FINGER PULSE OXIMETER, MODEL 9550
Applicant
NONIN MEDICAL, INC.
13700 1ST AVE. NORTH
PLYMOUTH,  MN  55441 -5443
Applicant Contact LORI M ROTH
Correspondent
NONIN MEDICAL, INC.
13700 1ST AVE. NORTH
PLYMOUTH,  MN  55441 -5443
Correspondent Contact LORI M ROTH
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/02/2005
Decision Date 06/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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