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 a medical device manufactured by Surgical Instrument Service and Savings Inc (Dba Medline. It received FDA 510(k) clearance on 2019-03-22 under approval 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. It is manufactured by Surgical Instrument Service and Savings Inc (Dba Medline. The 510(k) number is K181738.

When was Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors approved by the FDA?

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

What company makes Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors?

Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors is manufactured by Surgical Instrument Service and Savings Inc (Dba Medline.

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.

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Related Devices (Code: DQA)

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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.