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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 K211140
Device Name Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2
Applicant
Stryker Sustainability Solutions
1810 W Dr.Ake Dr.
Tempe,  AZ  85283
Applicant Contact Moira Barton-Varty
Correspondent
Stryker Sustainability Solutions
1810 W Dr.Ake Dr.
Tempe,  AZ  85283
Correspondent Contact Moira Barton-Varty
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/16/2021
Decision Date 03/08/2022
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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