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FDA 510(k)

M5 Recorder

K-Number: K202456 · 2020-12-29

ApplicantGlobal Instrumentation, LLC
Decision Date2020-12-29
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M5 Recorder is a medical device manufactured by Global Instrumentation, LLC. It received FDA 510(k) clearance on 2020-12-29 under approval number K202456. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M5 Recorder?

M5 Recorder is a medical device that received FDA 510(k) clearance on 2020-12-29. It is manufactured by Global Instrumentation, LLC. The 510(k) number is K202456.

When was M5 Recorder approved by the FDA?

M5 Recorder received FDA 510(k) clearance on 2020-12-29, under approval number K202456.

What company makes M5 Recorder?

M5 Recorder is manufactured by Global Instrumentation, LLC.

What is the FDA product code for M5 Recorder?

The FDA product code for M5 Recorder is DSH.

Other Devices by Global Instrumentation, LLC

K152701Matrix Mini ECG Monitor K162463Matrix Data Management System

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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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