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FDA 510(k)

MediOMx

K-Number: K233331 · 2024-06-17

ApplicantPmx, Inc.
Decision Date2024-06-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MediOMx is a medical device manufactured by Pmx, Inc.. It received FDA 510(k) clearance on 2024-06-17 under approval number K233331. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MediOMx?

MediOMx is a medical device that received FDA 510(k) clearance on 2024-06-17. It is manufactured by Pmx, Inc.. The 510(k) number is K233331.

When was MediOMx approved by the FDA?

MediOMx received FDA 510(k) clearance on 2024-06-17, under approval number K233331.

What company makes MediOMx?

MediOMx is manufactured by Pmx, Inc..

What is the FDA product code for MediOMx?

The FDA product code for MediOMx is LLZ.

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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.

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