FDA 510(k)

ECOM Cardiac Output Monitoring System

K-Number: K172196 · 2017-09-19

Decision Date2017-09-19

Product CodeDSB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Ecom Medical, Inc.. The 510(k) number is K172196.

When was ECOM Cardiac Output Monitoring System approved by the FDA?

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

What company makes ECOM Cardiac Output Monitoring System?

ECOM Cardiac Output Monitoring System is manufactured by Ecom Medical, Inc..

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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Official Source

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