FDA 510(k)

HaloGUARD Protective Disc with CHG

Número K: K200641 · 2020-09-03

Data da decisão2020-09-03

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

HaloGUARD Protective Disc with CHG is the device name listed in this FDA 510(k) record. The listed applicant is Attwill Medical Solutions. It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K200641. 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 HaloGUARD Protective Disc with CHG?

HaloGUARD Protective Disc with CHG is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is Attwill Medical Solutions. The 510(k) number is K200641.

When did HaloGUARD Protective Disc with CHG receive FDA 510(k) clearance?

HaloGUARD Protective Disc with CHG received FDA 510(k) clearance on 2020-09-03, under 510(k) number K200641.

Who is the listed applicant for HaloGUARD Protective Disc with CHG?

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

What is the FDA product code for HaloGUARD Protective Disc with CHG?

The FDA product code for HaloGUARD Protective Disc with CHG is FRO. This falls under the Anesthesiology category.

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