FDA 510(k)

ECOM™ Cardiac Output Monitoring System

Número K: K172196 · 2017-09-19

Data da decisão2017-09-19

Código do produtoDSB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ECOM™ Cardiac Output Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Ecom Medical, Inc.. It received FDA 510(k) clearance on 2017-09-19 under 510(k) number K172196. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ECOM™ Cardiac Output Monitoring System?

ECOM™ Cardiac Output Monitoring System is a medical device that received FDA 510(k) clearance on 2017-09-19. The listed applicant is Ecom Medical, Inc.. The 510(k) number is K172196.

When did ECOM™ Cardiac Output Monitoring System receive FDA 510(k) clearance?

ECOM™ Cardiac Output Monitoring System received FDA 510(k) clearance on 2017-09-19, under 510(k) number K172196.

Who is the listed applicant for ECOM™ Cardiac Output Monitoring System?

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

What is the FDA product code for ECOM™ Cardiac Output Monitoring System?

The FDA product code for ECOM™ Cardiac Output Monitoring System is DSB.

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