FDA 510(k)

RONAVIS – FX (FX-001)

Número K: K250315 · 2025-08-01

Data da decisão2025-08-01

Código do produtoHTY

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

RONAVIS – FX (FX-001) is the device name listed in this FDA 510(k) record. The listed applicant is AIRS, Inc.. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K250315. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RONAVIS – FX (FX-001)?

RONAVIS – FX (FX-001) is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is AIRS, Inc.. The 510(k) number is K250315.

When did RONAVIS – FX (FX-001) receive FDA 510(k) clearance?

RONAVIS – FX (FX-001) received FDA 510(k) clearance on 2025-08-01, under 510(k) number K250315.

Who is the listed applicant for RONAVIS – FX (FX-001)?

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

What is the FDA product code for RONAVIS – FX (FX-001)?

The FDA product code for RONAVIS – FX (FX-001) is HTY.

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