FDA 510(k)

ECG CT Gating Device

Número K: K160350 · 2016-06-16

Data da decisão2016-06-16

Código do produtoJAK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ECG CT Gating Device is the device name listed in this FDA 510(k) record. The listed applicant is Neocoil, LLC. It received FDA 510(k) clearance on 2016-06-16 under 510(k) number K160350. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ECG CT Gating Device?

ECG CT Gating Device is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is Neocoil, LLC. The 510(k) number is K160350.

When did ECG CT Gating Device receive FDA 510(k) clearance?

ECG CT Gating Device received FDA 510(k) clearance on 2016-06-16, under 510(k) number K160350.

Who is the listed applicant for ECG CT Gating Device?

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

What is the FDA product code for ECG CT Gating Device?

The FDA product code for ECG CT Gating Device is JAK.

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