FDA 510(k)

Filtro e HME/Filtro Altera

Número K: K192713 · 2020-03-16

RequerenteMeditera Tibbi Malzeme San VE Tic AS

Data da decisão2020-03-16

Código do produtoCAH

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Altera Filter and HME/Filter is the device name listed in this FDA 510(k) record. The listed applicant is Meditera Tibbi Malzeme San VE Tic AS. It received FDA 510(k) clearance on 2020-03-16 under 510(k) number K192713. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Altera Filter and HME/Filter?

Altera Filter and HME/Filter is a medical device that received FDA 510(k) clearance on 2020-03-16. The listed applicant is Meditera Tibbi Malzeme San VE Tic AS. The 510(k) number is K192713.

When did Altera Filter and HME/Filter receive FDA 510(k) clearance?

Altera Filter and HME/Filter received FDA 510(k) clearance on 2020-03-16, under 510(k) number K192713.

Who is the listed applicant for Altera Filter and HME/Filter?

The FDA 510(k) record lists Meditera Tibbi Malzeme San VE Tic AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Altera Filter and HME/Filter?

The FDA product code for Altera Filter and HME/Filter is CAH.

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Fonte oficial

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