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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 K211138
Device Name Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), R
Applicant
Stryker Sustainability Solutions
1810 West Drake Drive
Tempe,  AZ  85283
Applicant Contact Mia Brown
Correspondent
Stryker Sustainability Solutions
1810 West Drake Drive
Tempe,  AZ  85283
Correspondent Contact Mia Brown
Regulation Number870.2700
Classification Product Code
NLF  
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
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