FDA 510(k)

ActTrust

Número K: K151784 · 2016-05-25

RequerenteCondor Instruments Ltda. - Epp

Data da decisão2016-05-25

Código do produtoLEL

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ActTrust is the device name listed in this FDA 510(k) record. The listed applicant is Condor Instruments Ltda. - Epp. It received FDA 510(k) clearance on 2016-05-25 under 510(k) number K151784. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ActTrust?

ActTrust is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Condor Instruments Ltda. - Epp. The 510(k) number is K151784.

When did ActTrust receive FDA 510(k) clearance?

ActTrust received FDA 510(k) clearance on 2016-05-25, under 510(k) number K151784.

Who is the listed applicant for ActTrust?

The FDA 510(k) record lists Condor Instruments Ltda. - Epp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ActTrust?

The FDA product code for ActTrust is LEL.

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