FDA 510(k)

Instalief

Número K: K172358 · 2018-01-10

Data da decisão2018-01-10

Código do produtoLKX

DecisãoSubstantially Equivalent

Resumo do dispositivo

Instalief is the device name listed in this FDA 510(k) record. The listed applicant is Privi Medical Pte, Ltd.. It received FDA 510(k) clearance on 2018-01-10 under 510(k) number K172358. The device is classified under product code LKX. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Instalief?

Instalief is a medical device that received FDA 510(k) clearance on 2018-01-10. The listed applicant is Privi Medical Pte, Ltd.. The 510(k) number is K172358.

When did Instalief receive FDA 510(k) clearance?

Instalief received FDA 510(k) clearance on 2018-01-10, under 510(k) number K172358.

Who is the listed applicant for Instalief?

The FDA 510(k) record lists Privi Medical Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Instalief?

The FDA product code for Instalief is LKX.

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