FDA 510(k)

SMD-Sr90-DA Radionuclide Brachytherapy Source

Número K: K163206 · 2016-12-15

RequerenteSalutaris Medical Devices, Inc.

Data da decisão2016-12-15

Código do produtoKXK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

SMD-Sr90-DA Radionuclide Brachytherapy Source is the device name listed in this FDA 510(k) record. The listed applicant is Salutaris Medical Devices, Inc.. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K163206. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SMD-Sr90-DA Radionuclide Brachytherapy Source?

SMD-Sr90-DA Radionuclide Brachytherapy Source is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Salutaris Medical Devices, Inc.. The 510(k) number is K163206.

When did SMD-Sr90-DA Radionuclide Brachytherapy Source receive FDA 510(k) clearance?

SMD-Sr90-DA Radionuclide Brachytherapy Source received FDA 510(k) clearance on 2016-12-15, under 510(k) number K163206.

Who is the listed applicant for SMD-Sr90-DA Radionuclide Brachytherapy Source?

The FDA 510(k) record lists Salutaris Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMD-Sr90-DA Radionuclide Brachytherapy Source?

The FDA product code for SMD-Sr90-DA Radionuclide Brachytherapy Source is KXK.

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Fonte oficial

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