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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 K092101
Device Name REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 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 Received07/14/2009
Decision Date 10/21/2009
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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