Decision Date2020-07-22
Product CodeNLF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument and Savings Inc (Dba Medline Renewal). It received FDA 510(k) clearance on 2020-07-22 under 510(k) 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. The listed applicant is Surgical Instrument and Savings Inc (Dba Medline Renewal). The 510(k) number is K201699.
When did Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor receive FDA 510(k) clearance?
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor received FDA 510(k) clearance on 2020-07-22, under 510(k) number K201699.
Who is the listed applicant for Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor?
The FDA 510(k) record lists Surgical Instrument and Savings Inc (Dba Medline Renewal) as the applicant. This does not by itself establish the device manufacturer.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.