FDA 510(k)

BEAMSCAN

Número K: K161807 · 2017-05-19

RequerentePtw-Freiburg Physikalisch Technische-Werksraetten

Data da decisão2017-05-19

Código do produtoIYE

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

BEAMSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Ptw-Freiburg Physikalisch Technische-Werksraetten. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K161807. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BEAMSCAN?

BEAMSCAN is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Ptw-Freiburg Physikalisch Technische-Werksraetten. The 510(k) number is K161807.

When did BEAMSCAN receive FDA 510(k) clearance?

BEAMSCAN received FDA 510(k) clearance on 2017-05-19, under 510(k) number K161807.

Who is the listed applicant for BEAMSCAN?

The FDA 510(k) record lists Ptw-Freiburg Physikalisch Technische-Werksraetten as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEAMSCAN?

The FDA product code for BEAMSCAN is IYE.

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