FDA 510(k)

Snorer's Friend

Número K: K171529 · 2018-01-02

RequerenteScope Healthcare Technologies Pty, Ltd.

Data da decisão2018-01-02

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Snorer's Friend is the device name listed in this FDA 510(k) record. The listed applicant is Scope Healthcare Technologies Pty, Ltd.. It received FDA 510(k) clearance on 2018-01-02 under 510(k) number K171529. 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 Snorer's Friend?

Snorer's Friend is a medical device that received FDA 510(k) clearance on 2018-01-02. The listed applicant is Scope Healthcare Technologies Pty, Ltd.. The 510(k) number is K171529.

When did Snorer's Friend receive FDA 510(k) clearance?

Snorer's Friend received FDA 510(k) clearance on 2018-01-02, under 510(k) number K171529.

Who is the listed applicant for Snorer's Friend?

The FDA 510(k) record lists Scope Healthcare Technologies Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Snorer's Friend?

The FDA product code for Snorer's Friend is LRK.

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Fonte oficial

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