FDA 510(k)

Omeza Collagen Matrix

Número K: K211972 · 2021-09-01

Data da decisão2021-09-01

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Omeza Collagen Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Omeza, LLC. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K211972. 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 Omeza Collagen Matrix?

Omeza Collagen Matrix is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is Omeza, LLC. The 510(k) number is K211972.

When did Omeza Collagen Matrix receive FDA 510(k) clearance?

Omeza Collagen Matrix received FDA 510(k) clearance on 2021-09-01, under 510(k) number K211972.

Who is the listed applicant for Omeza Collagen Matrix?

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

What is the FDA product code for Omeza Collagen Matrix?

The FDA product code for Omeza Collagen Matrix is FRO. This falls under the Anesthesiology category.

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