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FDA 510(k)

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor

K-Number: K201699 · 2020-07-22

ApplicantSurgical Instrument and Savings Inc (Dba Medline Renewal)
Decision Date2020-07-22
Product CodeNLF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor is a medical device manufactured by Surgical Instrument and Savings Inc (Dba Medline Renewal). It received FDA 510(k) clearance on 2020-07-22 under approval number K201699. The device is classified under product code NLF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor?

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor is a medical device that received FDA 510(k) clearance on 2020-07-22. It is manufactured by Surgical Instrument and Savings Inc (Dba Medline Renewal). The 510(k) number is K201699.

When was Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor approved by the FDA?

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor received FDA 510(k) clearance on 2020-07-22, under approval number K201699.

What company makes Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor?

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor is manufactured by Surgical Instrument and Savings Inc (Dba Medline Renewal).

What is the FDA product code for Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor?

The FDA product code for Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor is NLF.

Related Devices (Code: NLF)

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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.

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