FDA 510(k)

Immucise Intradermal Injection System

Número K: K181369 · 2018-11-13

Data da decisão2018-11-13

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Immucise Intradermal Injection System is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corporation. It received FDA 510(k) clearance on 2018-11-13 under 510(k) number K181369. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Immucise Intradermal Injection System?

Immucise Intradermal Injection System is a medical device that received FDA 510(k) clearance on 2018-11-13. The listed applicant is Terumo Corporation. The 510(k) number is K181369.

When did Immucise Intradermal Injection System receive FDA 510(k) clearance?

Immucise Intradermal Injection System received FDA 510(k) clearance on 2018-11-13, under 510(k) number K181369.

Who is the listed applicant for Immucise Intradermal Injection System?

The FDA 510(k) record lists Terumo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Immucise Intradermal Injection System?

The FDA product code for Immucise Intradermal Injection System is FMI.

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