FDA 510(k)

Respond OC Conserving Regulator (130-0800)

Номер K: K250322 · 2025-07-24

Дата решения2025-07-24

Код продуктаNFB

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

Respond OC Conserving Regulator (130-0800) is the device name listed in this FDA 510(k) record. The listed applicant is Responsive Respiratory. It received FDA 510(k) clearance on 2025-07-24 under 510(k) number K250322. 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 Respond OC Conserving Regulator (130-0800)?

Respond OC Conserving Regulator (130-0800) is a medical device that received FDA 510(k) clearance on 2025-07-24. The listed applicant is Responsive Respiratory. The 510(k) number is K250322.

When did Respond OC Conserving Regulator (130-0800) receive FDA 510(k) clearance?

Respond OC Conserving Regulator (130-0800) received FDA 510(k) clearance on 2025-07-24, under 510(k) number K250322.

Who is the listed applicant for Respond OC Conserving Regulator (130-0800)?

The FDA 510(k) record lists Responsive Respiratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Respond OC Conserving Regulator (130-0800)?

The FDA product code for Respond OC Conserving Regulator (130-0800) 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)

K220591ProximaDynasthetics, LLC K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLC K200401ApogeeIncoba Ltd D/B/A Dynaris K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter Labs

Официальный источник

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