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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pulse Oximeter For Over-The-Counter Use
510(k) Number K211498
Device Name Nonin OTC Pulse Oximeter Model 3250
Applicant
Nonin Medical, Inc.
13700 1st Ave. N
Plymouth,  MN  55441
Applicant Contact Lisa Pray
Correspondent
Covance by Labcorp
13700 1st Ave. N
Plymouth,  MN  55441
Correspondent Contact Sheila Mena
Regulation Number870.2700
Classification Product Code
OLK  
Date Received05/14/2021
Decision Date 11/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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