FDA 510(k)

Respire Pink AT (Hard, Hard/Soft, EF)

Número K: K192127 · 2020-02-05

Data da decisão2020-02-05

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Respire Pink AT (Hard, Hard/Soft, EF) is the device name listed in this FDA 510(k) record. The listed applicant is Respire Medical Holdings. It received FDA 510(k) clearance on 2020-02-05 under 510(k) number K192127. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Respire Pink AT (Hard, Hard/Soft, EF)?

Respire Pink AT (Hard, Hard/Soft, EF) is a medical device that received FDA 510(k) clearance on 2020-02-05. The listed applicant is Respire Medical Holdings. The 510(k) number is K192127.

When did Respire Pink AT (Hard, Hard/Soft, EF) receive FDA 510(k) clearance?

Respire Pink AT (Hard, Hard/Soft, EF) received FDA 510(k) clearance on 2020-02-05, under 510(k) number K192127.

Who is the listed applicant for Respire Pink AT (Hard, Hard/Soft, EF)?

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

What is the FDA product code for Respire Pink AT (Hard, Hard/Soft, EF)?

The FDA product code for Respire Pink AT (Hard, Hard/Soft, EF) is LRK.

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