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FDA 510(k)

O2asis Personal Oxygen Humidifier

K-Number: K193411 · 2020-11-12

ApplicantPerma Pure, LLC
Decision Date2020-11-12
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

O2asis Personal Oxygen Humidifier is a medical device manufactured by Perma Pure, LLC. It received FDA 510(k) clearance on 2020-11-12 under approval number K193411. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O2asis Personal Oxygen Humidifier?

O2asis Personal Oxygen Humidifier is a medical device that received FDA 510(k) clearance on 2020-11-12. It is manufactured by Perma Pure, LLC. The 510(k) number is K193411.

When was O2asis Personal Oxygen Humidifier approved by the FDA?

O2asis Personal Oxygen Humidifier received FDA 510(k) clearance on 2020-11-12, under approval number K193411.

What company makes O2asis Personal Oxygen Humidifier?

O2asis Personal Oxygen Humidifier is manufactured by Perma Pure, LLC.

What is the FDA product code for O2asis Personal Oxygen Humidifier?

The FDA product code for O2asis Personal Oxygen Humidifier is BTT.

Related Clinical Trials

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Related Devices (Code: BTT)

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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.

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