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FDA 510(k)

eCordum Cardiac Monitor (eCordum CM)

K-Number: K193296 · 2020-10-30

ApplicantEcordum, Inc.
Decision Date2020-10-30
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

eCordum Cardiac Monitor (eCordum CM) is a medical device manufactured by Ecordum, Inc.. It received FDA 510(k) clearance on 2020-10-30 under approval number K193296. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eCordum Cardiac Monitor (eCordum CM)?

eCordum Cardiac Monitor (eCordum CM) is a medical device that received FDA 510(k) clearance on 2020-10-30. It is manufactured by Ecordum, Inc.. The 510(k) number is K193296.

When was eCordum Cardiac Monitor (eCordum CM) approved by the FDA?

eCordum Cardiac Monitor (eCordum CM) received FDA 510(k) clearance on 2020-10-30, under approval number K193296.

What company makes eCordum Cardiac Monitor (eCordum CM)?

eCordum Cardiac Monitor (eCordum CM) is manufactured by Ecordum, Inc..

What is the FDA product code for eCordum Cardiac Monitor (eCordum CM)?

The FDA product code for eCordum Cardiac Monitor (eCordum CM) is DXH. This falls under the Hematology category.

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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.

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