FDA 510(k)

Atrauman® Ag

Número K: K242758 · 2024-12-09

Data da decisão2024-12-09

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Atrauman® Ag is the device name listed in this FDA 510(k) record. The listed applicant is Hartmann USA, Inc.. It received FDA 510(k) clearance on 2024-12-09 under 510(k) number K242758. 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 Atrauman® Ag?

Atrauman® Ag is a medical device that received FDA 510(k) clearance on 2024-12-09. The listed applicant is Hartmann USA, Inc.. The 510(k) number is K242758.

When did Atrauman® Ag receive FDA 510(k) clearance?

Atrauman® Ag received FDA 510(k) clearance on 2024-12-09, under 510(k) number K242758.

Who is the listed applicant for Atrauman® Ag?

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

What is the FDA product code for Atrauman® Ag?

The FDA product code for Atrauman® Ag is FRO. This falls under the Anesthesiology category.

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