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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 the device name listed in this FDA 510(k) record. The listed applicant is Bionit Labs Srl. It received FDA 510(k) clearance on 2026-03-12 under 510(k) 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. The listed applicant is Bionit Labs Srl. The 510(k) number is K260453.

When did Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) receive FDA 510(k) clearance?

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

Who is the listed applicant for Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)?

The FDA 510(k) record lists Bionit Labs Srl as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Bionit Labs Srl as applicant

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.

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

Related Devices (Code: GXY)

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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