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FDA 510(k)

Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)

K-Number: K260453 · 2026-03-12

ApplicantBionit Labs Srl
Decision Date2026-03-12
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) is a medical device manufactured by Bionit Labs Srl. It received FDA 510(k) clearance on 2026-03-12 under approval number K260453. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)?

Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) is a medical device that received FDA 510(k) clearance on 2026-03-12. It is manufactured by Bionit Labs Srl. The 510(k) number is K260453.

When was Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) approved by the FDA?

Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) received FDA 510(k) clearance on 2026-03-12, under approval number K260453.

What company makes Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)?

Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) is manufactured by Bionit Labs Srl.

What is the FDA product code for Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)?

The FDA product code for Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) is GXY.

Related Clinical Trials

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Other Devices by Bionit Labs Srl

K242326Wave Electrode (AE02-60); Wave Electrode (AE02-50)

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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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