FDA 510(k)

Matrix Mini ECG Monitor

K-Number: K152701 · 2016-04-22

Decision Date2016-04-22

Product CodeDSI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Matrix Mini ECG Monitor is a medical device manufactured by Global Instrumentation, LLC. It received FDA 510(k) clearance on 2016-04-22 under approval number K152701. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Matrix Mini ECG Monitor?

Matrix Mini ECG Monitor is a medical device that received FDA 510(k) clearance on 2016-04-22. It is manufactured by Global Instrumentation, LLC. The 510(k) number is K152701.

When was Matrix Mini ECG Monitor approved by the FDA?

Matrix Mini ECG Monitor received FDA 510(k) clearance on 2016-04-22, under approval number K152701.

What company makes Matrix Mini ECG Monitor?

Matrix Mini ECG Monitor is manufactured by Global Instrumentation, LLC.

What is the FDA product code for Matrix Mini ECG Monitor?

The FDA product code for Matrix Mini ECG Monitor is DSI.

Other Devices by Global Instrumentation, LLC

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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.