FDA 510(k)

OWL RF INSULATED CANNULAE

Número K: K170708 · 2017-06-27

Data da decisão2017-06-27

Código do produtoGXI

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

OWL RF INSULATED CANNULAE is the device name listed in this FDA 510(k) record. The listed applicant is Diros Technology, Inc.. It received FDA 510(k) clearance on 2017-06-27 under 510(k) number K170708. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OWL RF INSULATED CANNULAE?

OWL RF INSULATED CANNULAE is a medical device that received FDA 510(k) clearance on 2017-06-27. The listed applicant is Diros Technology, Inc.. The 510(k) number is K170708.

When did OWL RF INSULATED CANNULAE receive FDA 510(k) clearance?

OWL RF INSULATED CANNULAE received FDA 510(k) clearance on 2017-06-27, under 510(k) number K170708.

Who is the listed applicant for OWL RF INSULATED CANNULAE?

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

What is the FDA product code for OWL RF INSULATED CANNULAE?

The FDA product code for OWL RF INSULATED CANNULAE is GXI.

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