FDA 510(k)

SIR-Spheres Microspheres Activity Calculator (SMAC)

Número K: K202392 · 2020-10-23

RequerenteSirtex Medical US Holdings, Inc.

Data da decisão2020-10-23

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

SIR-Spheres Microspheres Activity Calculator (SMAC) is the device name listed in this FDA 510(k) record. The listed applicant is Sirtex Medical US Holdings, Inc.. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K202392. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SIR-Spheres Microspheres Activity Calculator (SMAC)?

SIR-Spheres Microspheres Activity Calculator (SMAC) is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Sirtex Medical US Holdings, Inc.. The 510(k) number is K202392.

When did SIR-Spheres Microspheres Activity Calculator (SMAC) receive FDA 510(k) clearance?

SIR-Spheres Microspheres Activity Calculator (SMAC) received FDA 510(k) clearance on 2020-10-23, under 510(k) number K202392.

Who is the listed applicant for SIR-Spheres Microspheres Activity Calculator (SMAC)?

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

What is the FDA product code for SIR-Spheres Microspheres Activity Calculator (SMAC)?

The FDA product code for SIR-Spheres Microspheres Activity Calculator (SMAC) is KPS.

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Dispositivos Relacionados (Código: KPS)

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