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FDA 510(k)

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)

Número K: K251611 · 2025-06-25

RequerenteFisher & Paykel Healthcare, Ltd.
Data da decisão2025-06-25
Código do produtoBTT
Comité consultivoAN
DecisãoSubstantially Equivalent

Resumo do dispositivo

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2025-06-25 under 510(k) number K251611. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)?

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K251611.

When did Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) receive FDA 510(k) clearance?

Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) received FDA 510(k) clearance on 2025-06-25, under 510(k) number K251611.

Who is the listed applicant for Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)?

The FDA 510(k) record lists Fisher & Paykel Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)?

The FDA product code for Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) is BTT.

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Fonte oficial

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