FDA 510(k)

ICU Health Surgical Mask

Número K: K203064 · 2021-03-23

Data da decisão2021-03-23

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ICU Health Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Plastikon Industries. It received FDA 510(k) clearance on 2021-03-23 under 510(k) number K203064. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ICU Health Surgical Mask?

ICU Health Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-03-23. The listed applicant is Plastikon Industries. The 510(k) number is K203064.

When did ICU Health Surgical Mask receive FDA 510(k) clearance?

ICU Health Surgical Mask received FDA 510(k) clearance on 2021-03-23, under 510(k) number K203064.

Who is the listed applicant for ICU Health Surgical Mask?

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

What is the FDA product code for ICU Health Surgical Mask?

The FDA product code for ICU Health Surgical Mask is FXX.

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