FDA 510(k)

Titan Ag 200

Número K: K173844 · 2018-08-09

RequerenteSpecialty Fibres and Materials, Ltd.

Data da decisão2018-08-09

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Titan Ag 200 is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Fibres and Materials, Ltd.. It received FDA 510(k) clearance on 2018-08-09 under 510(k) number K173844. 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 Titan Ag 200?

Titan Ag 200 is a medical device that received FDA 510(k) clearance on 2018-08-09. The listed applicant is Specialty Fibres and Materials, Ltd.. The 510(k) number is K173844.

When did Titan Ag 200 receive FDA 510(k) clearance?

Titan Ag 200 received FDA 510(k) clearance on 2018-08-09, under 510(k) number K173844.

Who is the listed applicant for Titan Ag 200?

The FDA 510(k) record lists Specialty Fibres and Materials, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Titan Ag 200?

The FDA product code for Titan Ag 200 is FRO. This falls under the Anesthesiology category.

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Fonte oficial

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