FDA 510(k)

Surefire Infusion System

Número K: K160662 · 2016-03-11

Data da decisão2016-03-11

Código do produtoDQO

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surefire Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Surefire Medical, Inc.. It received FDA 510(k) clearance on 2016-03-11 under 510(k) number K160662. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Surefire Infusion System?

Surefire Infusion System is a medical device that received FDA 510(k) clearance on 2016-03-11. The listed applicant is Surefire Medical, Inc.. The 510(k) number is K160662.

When did Surefire Infusion System receive FDA 510(k) clearance?

Surefire Infusion System received FDA 510(k) clearance on 2016-03-11, under 510(k) number K160662.

Who is the listed applicant for Surefire Infusion System?

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

What is the FDA product code for Surefire Infusion System?

The FDA product code for Surefire Infusion System is DQO.

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Outros registros que listam Surefire Medical, Inc. como candidato(a)

K180677Surefire Spark Infusion System K171355Surefire Precision Infusion System K162359Surefire Guiding Catheter

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Fonte oficial

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