FDA 510(k)

CRIT-LINE III Blood Chamber II

Número K: K160749 · 2016-04-15

RequerenteFresenius Medical Care Renal Therapies Group, LLC

Data da decisão2016-04-15

Código do produtoKOC

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CRIT-LINE III Blood Chamber II is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K160749. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CRIT-LINE III Blood Chamber II?

CRIT-LINE III Blood Chamber II is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K160749.

When did CRIT-LINE III Blood Chamber II receive FDA 510(k) clearance?

CRIT-LINE III Blood Chamber II received FDA 510(k) clearance on 2016-04-15, under 510(k) number K160749.

Who is the listed applicant for CRIT-LINE III Blood Chamber II?

The FDA 510(k) record lists Fresenius Medical Care Renal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRIT-LINE III Blood Chamber II?

The FDA product code for CRIT-LINE III Blood Chamber II is KOC.

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Fonte oficial

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