FDA 510(k)

Respire Pink Series with DentiTrac

Número K: K170692 · 2017-05-26

Data da decisão2017-05-26

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Respire Pink Series with DentiTrac is the device name listed in this FDA 510(k) record. The listed applicant is Respire Medical Holding. It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K170692. 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 Series with DentiTrac?

Respire Pink Series with DentiTrac is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Respire Medical Holding. The 510(k) number is K170692.

When did Respire Pink Series with DentiTrac receive FDA 510(k) clearance?

Respire Pink Series with DentiTrac received FDA 510(k) clearance on 2017-05-26, under 510(k) number K170692.

Who is the listed applicant for Respire Pink Series with DentiTrac?

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

What is the FDA product code for Respire Pink Series with DentiTrac?

The FDA product code for Respire Pink Series with DentiTrac is LRK.

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