FDA 510(k)

Dosimetry Check Version 5 Release 1

Número K: K162577 · 2016-11-18

Data da decisão2016-11-18

Código do produtoIYE

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dosimetry Check Version 5 Release 1 is the device name listed in this FDA 510(k) record. The listed applicant is Math Resolutions, LLC. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K162577. 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 Dosimetry Check Version 5 Release 1?

Dosimetry Check Version 5 Release 1 is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Math Resolutions, LLC. The 510(k) number is K162577.

When did Dosimetry Check Version 5 Release 1 receive FDA 510(k) clearance?

Dosimetry Check Version 5 Release 1 received FDA 510(k) clearance on 2016-11-18, under 510(k) number K162577.

Who is the listed applicant for Dosimetry Check Version 5 Release 1?

The FDA 510(k) record lists Math Resolutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dosimetry Check Version 5 Release 1?

The FDA product code for Dosimetry Check Version 5 Release 1 is IYE.

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