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FDA 510(k)

Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile

K-Number: K221014 · 2022-10-17

ApplicantEffortless Oxygen, LLC
Decision Date2022-10-17
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Effortless Oxygen, LLC. It received FDA 510(k) clearance on 2022-10-17 under 510(k) number K221014. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile?

Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile is a medical device that received FDA 510(k) clearance on 2022-10-17. The listed applicant is Effortless Oxygen, LLC. The 510(k) number is K221014.

When did Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile receive FDA 510(k) clearance?

Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile received FDA 510(k) clearance on 2022-10-17, under 510(k) number K221014.

Who is the listed applicant for Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile?

The FDA 510(k) record lists Effortless Oxygen, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile?

The FDA product code for Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile is NFB.

Related Devices (Code: NFB)

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.

K250322Respond OC Conserving Regulator (130-0800)Responsive RespiratoryK220591ProximaDynasthetics, LLCK200401ApogeeIncoba Ltd D/B/A DynarisK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter Labs

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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