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FDA 510(k)

Breathe Technologies Life2000™ Ventilation System

Número K: K170037 · 2017-08-11

RequerenteBreathe Technologies
Data da decisão2017-08-11
Código do produtoCBK
Comité consultivoAN
DecisãoSubstantially Equivalent

Resumo do dispositivo

Breathe Technologies Life2000™ Ventilation System is the device name listed in this FDA 510(k) record. The listed applicant is Breathe Technologies. It received FDA 510(k) clearance on 2017-08-11 under 510(k) number K170037. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Breathe Technologies Life2000™ Ventilation System?

Breathe Technologies Life2000™ Ventilation System is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is Breathe Technologies. The 510(k) number is K170037.

When did Breathe Technologies Life2000™ Ventilation System receive FDA 510(k) clearance?

Breathe Technologies Life2000™ Ventilation System received FDA 510(k) clearance on 2017-08-11, under 510(k) number K170037.

Who is the listed applicant for Breathe Technologies Life2000™ Ventilation System?

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

What is the FDA product code for Breathe Technologies Life2000™ Ventilation System?

The FDA product code for Breathe Technologies Life2000™ Ventilation System is CBK.

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Fonte oficial

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