FDA 510(k)

Pollogen Legend+ System

Número K: K171359 · 2017-09-13

Data da decisão2017-09-13

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pollogen Legend+ System is the device name listed in this FDA 510(k) record. The listed applicant is Pollogen, Ltd.. It received FDA 510(k) clearance on 2017-09-13 under 510(k) number K171359. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pollogen Legend+ System?

Pollogen Legend+ System is a medical device that received FDA 510(k) clearance on 2017-09-13. The listed applicant is Pollogen, Ltd.. The 510(k) number is K171359.

When did Pollogen Legend+ System receive FDA 510(k) clearance?

Pollogen Legend+ System received FDA 510(k) clearance on 2017-09-13, under 510(k) number K171359.

Who is the listed applicant for Pollogen Legend+ System?

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

What is the FDA product code for Pollogen Legend+ System?

The FDA product code for Pollogen Legend+ System is GEI.

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Fonte oficial

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