FDA 510(k)

StarFin

Número K: K231407 · 2023-08-29

RequerentePremium Medical Technology, LLC

Data da decisão2023-08-29

Código do produtoHIF

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

StarFin is the device name listed in this FDA 510(k) record. The listed applicant is Premium Medical Technology, LLC. It received FDA 510(k) clearance on 2023-08-29 under 510(k) number K231407. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the StarFin?

StarFin is a medical device that received FDA 510(k) clearance on 2023-08-29. The listed applicant is Premium Medical Technology, LLC. The 510(k) number is K231407.

When did StarFin receive FDA 510(k) clearance?

StarFin received FDA 510(k) clearance on 2023-08-29, under 510(k) number K231407.

Who is the listed applicant for StarFin?

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

What is the FDA product code for StarFin?

The FDA product code for StarFin is HIF.

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