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FDA 510(k)

Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors

K-Number: K181738 · 2019-03-22

ApplicantSurgical Instrument Service and Savings Inc (Dba Medline
Decision Date2019-03-22
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings Inc (Dba Medline. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K181738. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors?

Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Surgical Instrument Service and Savings Inc (Dba Medline. The 510(k) number is K181738.

When did Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors receive FDA 510(k) clearance?

Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors received FDA 510(k) clearance on 2019-03-22, under 510(k) number K181738.

Who is the listed applicant for Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors?

The FDA 510(k) record lists Surgical Instrument Service and Savings Inc (Dba Medline as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors?

The FDA product code for Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors is DQA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06148623Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin PigmentationCOMPLETEDNCT06432881Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)COMPLETEDNCT07221526SPO2 VALIDATION STUDY - PHILIPS FAST 2025COMPLETEDNCT07753863Use of a Silicone Sensor to Protect Fragile Neonatal Skin in Moderately Preterm Infants Needing Continuous MonitoringNOT_YET_RECRUITING

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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