FDA 510(k)

Curasite

Número K: K161991 · 2017-03-03

Data da decisão2017-03-03

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Curasite is the device name listed in this FDA 510(k) record. The listed applicant is Izun Pharmaceuticals. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K161991. 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 Curasite?

Curasite is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Izun Pharmaceuticals. The 510(k) number is K161991.

When did Curasite receive FDA 510(k) clearance?

Curasite received FDA 510(k) clearance on 2017-03-03, under 510(k) number K161991.

Who is the listed applicant for Curasite?

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

What is the FDA product code for Curasite?

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

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