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FDA 510(k)

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile

K-Number: K181310 · 2019-02-22

ApplicantCardiocomm Solutions, Inc.
Decision Date2019-02-22
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile is a medical device manufactured by Cardiocomm Solutions, Inc.. It received FDA 510(k) clearance on 2019-02-22 under approval number K181310. 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 HeartCheck Cardi Beat ECG Monitor with GEMS Mobile?

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile is a medical device that received FDA 510(k) clearance on 2019-02-22. It is manufactured by Cardiocomm Solutions, Inc.. The 510(k) number is K181310.

When was HeartCheck Cardi Beat ECG Monitor with GEMS Mobile approved by the FDA?

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile received FDA 510(k) clearance on 2019-02-22, under approval number K181310.

What company makes HeartCheck Cardi Beat ECG Monitor with GEMS Mobile?

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile is manufactured by Cardiocomm Solutions, Inc..

What is the FDA product code for HeartCheck Cardi Beat ECG Monitor with GEMS Mobile?

The FDA product code for HeartCheck Cardi Beat ECG Monitor with GEMS Mobile 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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