FDA 510(k)

BIAFINE

Número K: K173549 · 2018-08-13

Data da decisão2018-08-13

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

BIAFINE is the device name listed in this FDA 510(k) record. The listed applicant is Valeant Pharmaceuticals. It received FDA 510(k) clearance on 2018-08-13 under 510(k) number K173549. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BIAFINE?

BIAFINE is a medical device that received FDA 510(k) clearance on 2018-08-13. The listed applicant is Valeant Pharmaceuticals. The 510(k) number is K173549.

When did BIAFINE receive FDA 510(k) clearance?

BIAFINE received FDA 510(k) clearance on 2018-08-13, under 510(k) number K173549.

Who is the listed applicant for BIAFINE?

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

What is the FDA product code for BIAFINE?

The FDA product code for BIAFINE is FRO. This falls under the Anesthesiology category.

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