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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 the device name listed in this FDA 510(k) record. The listed applicant is Axeo Medical Technologies, LLC. It received FDA 510(k) clearance on 2016-03-17 under 510(k) 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. The listed applicant is Axeo Medical Technologies, LLC. The 510(k) number is K153079.

When did Axeo 3 Patient Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for Axeo 3 Patient Monitor?

The FDA 510(k) record lists Axeo Medical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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