FDA 510(k)

Software de Ejeção Fracionária Automática EchoMD

Número K: K173780 · 2018-06-14

Data da decisão2018-06-14

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

EchoMD Automated Ejection Fraction Software is the device name listed in this FDA 510(k) record. The listed applicant is Bay Labs, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K173780. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EchoMD Automated Ejection Fraction Software?

EchoMD Automated Ejection Fraction Software is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Bay Labs, Inc.. The 510(k) number is K173780.

When did EchoMD Automated Ejection Fraction Software receive FDA 510(k) clearance?

EchoMD Automated Ejection Fraction Software received FDA 510(k) clearance on 2018-06-14, under 510(k) number K173780.

Who is the listed applicant for EchoMD Automated Ejection Fraction Software?

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

What is the FDA product code for EchoMD Automated Ejection Fraction Software?

The FDA product code for EchoMD Automated Ejection Fraction Software is LLZ.

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