FDA 510(k)

PROcedure Rehearsal Studio

Número K: K153705 · 2016-09-02

Data da decisão2016-09-02

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

PROcedure Rehearsal Studio is the device name listed in this FDA 510(k) record. The listed applicant is 3Dsystems, Simbionix Products. It received FDA 510(k) clearance on 2016-09-02 under 510(k) number K153705. 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 PROcedure Rehearsal Studio?

PROcedure Rehearsal Studio is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is 3Dsystems, Simbionix Products. The 510(k) number is K153705.

When did PROcedure Rehearsal Studio receive FDA 510(k) clearance?

PROcedure Rehearsal Studio received FDA 510(k) clearance on 2016-09-02, under 510(k) number K153705.

Who is the listed applicant for PROcedure Rehearsal Studio?

The FDA 510(k) record lists 3Dsystems, Simbionix Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROcedure Rehearsal Studio?

The FDA product code for PROcedure Rehearsal Studio is LLZ.

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