FDA 510(k)

Vscan Extend

Número K: K161588 · 2016-08-31

RequerenteGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Data da decisão2016-08-31

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vscan Extend is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2016-08-31 under 510(k) number K161588. 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 Vscan Extend?

Vscan Extend is a medical device that received FDA 510(k) clearance on 2016-08-31. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K161588.

When did Vscan Extend receive FDA 510(k) clearance?

Vscan Extend received FDA 510(k) clearance on 2016-08-31, under 510(k) number K161588.

Who is the listed applicant for Vscan Extend?

The FDA 510(k) record lists GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vscan Extend?

The FDA product code for Vscan Extend is IYN.

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Fonte oficial

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