FDA 510(k)

Cerdak Basic

Número K: K153138 · 2017-06-23

RequerenteBu Polysciences Equipment & Trading, LLC

Data da decisão2017-06-23

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cerdak Basic is the device name listed in this FDA 510(k) record. The listed applicant is Bu Polysciences Equipment & Trading, LLC. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K153138. 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 Cerdak Basic?

Cerdak Basic is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Bu Polysciences Equipment & Trading, LLC. The 510(k) number is K153138.

When did Cerdak Basic receive FDA 510(k) clearance?

Cerdak Basic received FDA 510(k) clearance on 2017-06-23, under 510(k) number K153138.

Who is the listed applicant for Cerdak Basic?

The FDA 510(k) record lists Bu Polysciences Equipment & Trading, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cerdak Basic?

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

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Fonte oficial

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