FDA 510(k)

McLaren Proton Therapy System

Número K: K160063 · 2016-02-25

RequerenteMclaren Health Care Corporation

Data da decisão2016-02-25

Código do produtoLHN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

McLaren Proton Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Mclaren Health Care Corporation. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K160063. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the McLaren Proton Therapy System?

McLaren Proton Therapy System is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Mclaren Health Care Corporation. The 510(k) number is K160063.

When did McLaren Proton Therapy System receive FDA 510(k) clearance?

McLaren Proton Therapy System received FDA 510(k) clearance on 2016-02-25, under 510(k) number K160063.

Who is the listed applicant for McLaren Proton Therapy System?

The FDA 510(k) record lists Mclaren Health Care Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for McLaren Proton Therapy System?

The FDA product code for McLaren Proton Therapy System is LHN.

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