FDA 510(k)

OptoWire Deux

Número K: K152991 · 2016-02-11

RequerenteOpsens

Data da decisão2016-02-11

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

OptoWire Deux is the device name listed in this FDA 510(k) record. The listed applicant is Opsens. It received FDA 510(k) clearance on 2016-02-11 under 510(k) number K152991. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OptoWire Deux?

OptoWire Deux is a medical device that received FDA 510(k) clearance on 2016-02-11. The listed applicant is Opsens. The 510(k) number is K152991.

When did OptoWire Deux receive FDA 510(k) clearance?

OptoWire Deux received FDA 510(k) clearance on 2016-02-11, under 510(k) number K152991.

Who is the listed applicant for OptoWire Deux?

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

What is the FDA product code for OptoWire Deux?

The FDA product code for OptoWire Deux is DQX.

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