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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 K222019
Device Name Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
Applicant
Stryker Sustainability Solutions
1810 W Drake Drive
Tempe,  AZ  85283
Applicant Contact Michael Wong
Correspondent
Stryker Sustainability Solutions
1810 W Drake Drive
Tempe,  AZ  85283
Correspondent Contact Michael Wong
Regulation Number870.2700
Classification Product Code
NLF  
Subsequent Product Code
DQA  
Date Received07/08/2022
Decision Date 12/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT05245526
NCT05264116
Reviewed by Third Party No
Combination Product No
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