FDA 510(k)

ADI Medical Surgical Face Mask

Número K: K213347 · 2022-01-25

RequerenteAsia Dynamics Inc., D/B/A Adi Medical

Data da decisão2022-01-25

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ADI Medical Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Asia Dynamics Inc., D/B/A Adi Medical. It received FDA 510(k) clearance on 2022-01-25 under 510(k) number K213347. 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 ADI Medical Surgical Face Mask?

ADI Medical Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2022-01-25. The listed applicant is Asia Dynamics Inc., D/B/A Adi Medical. The 510(k) number is K213347.

When did ADI Medical Surgical Face Mask receive FDA 510(k) clearance?

ADI Medical Surgical Face Mask received FDA 510(k) clearance on 2022-01-25, under 510(k) number K213347.

Who is the listed applicant for ADI Medical Surgical Face Mask?

The FDA 510(k) record lists Asia Dynamics Inc., D/B/A Adi Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADI Medical Surgical Face Mask?

The FDA product code for ADI Medical Surgical Face Mask is FXX.

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