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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 K160231
Device Name Model X-100C CO-Met™ Oximetry System
Applicant
Nonin Medical, Inc.
13700 1st Ave. N
Plymouth,  MN  55441
Applicant Contact KIM E. AVES
Correspondent
Nonin Medical, Inc.
13700 1st Ave. N
Plymouth,  MN  55441
Correspondent Contact KIM E. AVES
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/01/2016
Decision Date 12/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT02262195
NCT02427685
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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