FDA 510(k)

High Flow Insufflation Unit (UHI-4)

Número K: K243527 · 2025-01-13

RequerenteOlympus Medical Systems Corporation

Data da decisão2025-01-13

Código do produtoHIF

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

High Flow Insufflation Unit (UHI-4) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K243527. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the High Flow Insufflation Unit (UHI-4)?

High Flow Insufflation Unit (UHI-4) is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K243527.

When did High Flow Insufflation Unit (UHI-4) receive FDA 510(k) clearance?

High Flow Insufflation Unit (UHI-4) received FDA 510(k) clearance on 2025-01-13, under 510(k) number K243527.

Who is the listed applicant for High Flow Insufflation Unit (UHI-4)?

The FDA 510(k) record lists Olympus Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High Flow Insufflation Unit (UHI-4)?

The FDA product code for High Flow Insufflation Unit (UHI-4) is HIF.

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Fonte oficial

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