FDA 510(k)

Respond OC Conserving Regulator (130-0800)

Número K: K250322 · 2025-07-24

Data da decisão2025-07-24

Código do produtoNFB

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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