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FDA 510(k)

X-trodes System M

K-Number: K232210 · 2024-02-04

ApplicantX-Trodes
Decision Date2024-02-04
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

X-trodes System M is a medical device manufactured by X-Trodes. It received FDA 510(k) clearance on 2024-02-04 under approval number K232210. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-trodes System M?

X-trodes System M is a medical device that received FDA 510(k) clearance on 2024-02-04. It is manufactured by X-Trodes. The 510(k) number is K232210.

When was X-trodes System M approved by the FDA?

X-trodes System M received FDA 510(k) clearance on 2024-02-04, under approval number K232210.

What company makes X-trodes System M?

X-trodes System M is manufactured by X-Trodes.

What is the FDA product code for X-trodes System M?

The FDA product code for X-trodes System M is GWL.

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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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