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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 K172625
Device Name Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor
Applicant
Nonin Medical Inc.
13700 1st Avenue North
Plymouth,  MN  55441
Applicant Contact Kim E. Aves
Correspondent
Nonin Medical Inc.
13700 1st Avenue North
Plymouth,  MN  55441
Correspondent Contact Kim E. Aves
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/01/2017
Decision Date 05/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT03030833
Reviewed by Third Party No
Combination Product No
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