Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ECOM™ Cardiac Output Monitoring System

K-Number: K172196 · 2017-09-19

ApplicantEcom Medical, Inc.
Decision Date2017-09-19
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Devices (Code: DSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.K211585Bodyport Cardiac ScaleBodyport, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑