FDA.reportPublic FDA data

510(k) K211138

Device
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-
Applicant
Stryker Sustainability Solutions
510(k) number
K211138
Product code
NLF
Decision
Substantially Equivalent (SESE)
Decision date
2022-03-08
Date received
2021-04-16
Regulation
870.2700
Classification name
Oximeter, Reprocessed
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mia Brown
Address
1810 W Dr.Ake Dr. Tempe AZ US 85283 85283

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NLF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241758Reprocessed 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)Stryker Sustainability Solutions2024-10-22
K222019Reprocessed 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)Stryker Sustainability Solutions2022-12-04
K201699Medline ReNewal Reprocessed Nellcor OxiMax SpO2 SensorSurgical Instrument and Savings Inc (Dba Medline Renewal)2020-07-22
K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.2019-07-03
K111773RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATERenu Medical, Inc.2011-11-16
K110723M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORSMasimo Corporation2011-07-28
K102560REPROCESSED PULSE OXIMETER SENSORSSterilmed, Inc.2011-02-18
K101280MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBEMidwest Reprocessing Center, LLC2010-10-07
K092368REPROCESSED PULSE OXIMETER SENSORSSterilmed, Inc.2009-11-03
K083719LNCS OXIMETRY SENSORSMasimo Corporation2009-07-30
K081927RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEORenu Medical, Inc.2009-02-06
K081238REPROCESSED MASIMO PULSE OXIMETER SENSORSAscent Healthcare Solutions2008-07-29
K080424HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861Hygia Health Services, Inc.2008-05-28
K072194RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25Renu Medical, Inc.2007-11-29
K063661RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20Renu Medical, Inc.2007-05-25