FDA 510(k)

Compass Cast and MAP

Número K: K161408 · 2016-11-22

RequerenteCenturion Medical Products Corporation

Data da decisão2016-11-22

Código do produtoDRS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Compass Cast and MAP is the device name listed in this FDA 510(k) record. The listed applicant is Centurion Medical Products Corporation. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K161408. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Compass Cast and MAP?

Compass Cast and MAP is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Centurion Medical Products Corporation. The 510(k) number is K161408.

When did Compass Cast and MAP receive FDA 510(k) clearance?

Compass Cast and MAP received FDA 510(k) clearance on 2016-11-22, under 510(k) number K161408.

Who is the listed applicant for Compass Cast and MAP?

The FDA 510(k) record lists Centurion Medical Products Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Compass Cast and MAP?

The FDA product code for Compass Cast and MAP is DRS.

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Fonte oficial

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