FDA 510(k)

Communicator Surgical Facemask with Clear Window

Número K: K152561 · 2016-06-03

Data da decisão2016-06-03

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Communicator Surgical Facemask with Clear Window is the device name listed in this FDA 510(k) record. The listed applicant is Prestige Ameritech , Ltd.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K152561. 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 Communicator Surgical Facemask with Clear Window?

Communicator Surgical Facemask with Clear Window is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Prestige Ameritech , Ltd.. The 510(k) number is K152561.

When did Communicator Surgical Facemask with Clear Window receive FDA 510(k) clearance?

Communicator Surgical Facemask with Clear Window received FDA 510(k) clearance on 2016-06-03, under 510(k) number K152561.

Who is the listed applicant for Communicator Surgical Facemask with Clear Window?

The FDA 510(k) record lists Prestige Ameritech , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Communicator Surgical Facemask with Clear Window?

The FDA product code for Communicator Surgical Facemask with Clear Window is FXX.

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