FDA 510(k)

Sistema de Ultrassonografia Acuson Freestyle

Número K: K162417 · 2016-09-28

RequerenteSiemens Medi Cal Solutions, Inc.

Data da decisão2016-09-28

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Acuson Freestyle Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2016-09-28 under 510(k) number K162417. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Acuson Freestyle Ultrasound System?

Acuson Freestyle Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-09-28. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K162417.

When did Acuson Freestyle Ultrasound System receive FDA 510(k) clearance?

Acuson Freestyle Ultrasound System received FDA 510(k) clearance on 2016-09-28, under 510(k) number K162417.

Who is the listed applicant for Acuson Freestyle Ultrasound System?

The FDA 510(k) record lists Siemens Medi Cal Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acuson Freestyle Ultrasound System?

The FDA product code for Acuson Freestyle Ultrasound System is IYN.

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Fonte oficial

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