FDA 510(k)

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

Número K: K183128 · 2018-12-12

RequerenteAbbott

Data da decisão2018-12-12

Código do produtoDQK

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2018-12-12 under 510(k) number K183128. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2?

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 is a medical device that received FDA 510(k) clearance on 2018-12-12. The listed applicant is Abbott. The 510(k) number is K183128.

When did EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 receive FDA 510(k) clearance?

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 received FDA 510(k) clearance on 2018-12-12, under 510(k) number K183128.

Who is the listed applicant for EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2?

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

What is the FDA product code for EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2?

The FDA product code for EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 is DQK.

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Fonte oficial

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