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FDA 510(k)

Axeo 3 Patient Monitor

K-Number: K153079 · 2016-03-17

ApplicantAxeo Medical Technologies, LLC
Decision Date2016-03-17
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Axeo 3 Patient Monitor is a medical device manufactured by Axeo Medical Technologies, LLC. It received FDA 510(k) clearance on 2016-03-17 under approval number K153079. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Axeo 3 Patient Monitor?

Axeo 3 Patient Monitor is a medical device that received FDA 510(k) clearance on 2016-03-17. It is manufactured by Axeo Medical Technologies, LLC. The 510(k) number is K153079.

When was Axeo 3 Patient Monitor approved by the FDA?

Axeo 3 Patient Monitor received FDA 510(k) clearance on 2016-03-17, under approval number K153079.

What company makes Axeo 3 Patient Monitor?

Axeo 3 Patient Monitor is manufactured by Axeo Medical Technologies, LLC.

What is the FDA product code for Axeo 3 Patient Monitor?

The FDA product code for Axeo 3 Patient Monitor is MWI.

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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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