FDA 510(k)

Software de Ejection Fraction Automático EchoMD

N.º K: K173780 · 2018-06-14

Fecha de decisión2018-06-14

Código de productoLLZ

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Fuente oficial

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