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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter, reprocessed
510(k) Number K201699
Device Name Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
Surgical Instrument and Savings Inc (dba Medline ReNewal)
1500 NE Hemlock Ave
Redmond,  OR  97756
Applicant Contact Stephanie Boyle Mays
Surgical Instrument Service and Savings Inc (dba Medline ReN
1500 NE Hemlock Ave
Redmond,  OR  97756
Correspondent Contact Stephanie Boyle Mays
Regulation Number870.2700
Classification Product Code
Date Received06/22/2020
Decision Date 07/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No