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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 the device name listed in this FDA 510(k) record. The listed applicant is Ecordum, Inc.. It received FDA 510(k) clearance on 2020-10-30 under 510(k) 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. The listed applicant is Ecordum, Inc.. The 510(k) number is K193296.

When did eCordum Cardiac Monitor (eCordum CM) receive FDA 510(k) clearance?

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

Who is the listed applicant for eCordum Cardiac Monitor (eCordum CM)?

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

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

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

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