FDA 510(k)

Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile

Номер K: K221014 · 2022-10-17

Дата решения2022-10-17

Код продуктаNFB

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: NFB)

K250322Respond OC Conserving Regulator (130-0800)Responsive Respiratory K220591ProximaDynasthetics, LLC K200401ApogeeIncoba Ltd D/B/A Dynaris K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter Labs

Официальный источник

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