FDA 510(k)

MUSE Cardiology Information System

Número K: K152993 · 2016-01-12

RequerenteGe Medical Systems Information Technologies, Inc.

Data da decisão2016-01-12

Código do produtoDQK

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

MUSE Cardiology Information System is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2016-01-12 under 510(k) number K152993. 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 MUSE Cardiology Information System?

MUSE Cardiology Information System is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K152993.

When did MUSE Cardiology Information System receive FDA 510(k) clearance?

MUSE Cardiology Information System received FDA 510(k) clearance on 2016-01-12, under 510(k) number K152993.

Who is the listed applicant for MUSE Cardiology Information System?

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

What is the FDA product code for MUSE Cardiology Information System?

The FDA product code for MUSE Cardiology Information System is DQK.

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Fonte oficial

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