FDA 510(k)

ThermoShield HME Filter

Número K: K163300 · 2017-03-22

Data da decisão2017-03-22

Código do produtoCAH

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

ThermoShield HME Filter is the device name listed in this FDA 510(k) record. The listed applicant is Flexicare Medical Limited.. It received FDA 510(k) clearance on 2017-03-22 under 510(k) number K163300. 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 ThermoShield HME Filter?

ThermoShield HME Filter is a medical device that received FDA 510(k) clearance on 2017-03-22. The listed applicant is Flexicare Medical Limited.. The 510(k) number is K163300.

When did ThermoShield HME Filter receive FDA 510(k) clearance?

ThermoShield HME Filter received FDA 510(k) clearance on 2017-03-22, under 510(k) number K163300.

Who is the listed applicant for ThermoShield HME Filter?

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

What is the FDA product code for ThermoShield HME Filter?

The FDA product code for ThermoShield HME Filter is CAH.

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