FDA 510(k)

LVivo Software Application

Número K: K161382 · 2016-07-28

Data da decisão2016-07-28

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

LVivo Software Application is the device name listed in this FDA 510(k) record. The listed applicant is Diacardio, Ltd.. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161382. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LVivo Software Application?

LVivo Software Application is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Diacardio, Ltd.. The 510(k) number is K161382.

When did LVivo Software Application receive FDA 510(k) clearance?

LVivo Software Application received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161382.

Who is the listed applicant for LVivo Software Application?

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

What is the FDA product code for LVivo Software Application?

The FDA product code for LVivo Software Application is LLZ.

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