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FDA 510(k)

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

K-Number: K242326 · 2025-01-02

ApplicantBionit Labs Srl
Decision Date2025-01-02
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Wave Electrode (AE02-60); Wave Electrode (AE02-50) is a medical device manufactured by Bionit Labs Srl. It received FDA 510(k) clearance on 2025-01-02 under approval number K242326. 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 Wave Electrode (AE02-60); Wave Electrode (AE02-50)?

Wave Electrode (AE02-60); Wave Electrode (AE02-50) is a medical device that received FDA 510(k) clearance on 2025-01-02. It is manufactured by Bionit Labs Srl. The 510(k) number is K242326.

When was Wave Electrode (AE02-60); Wave Electrode (AE02-50) approved by the FDA?

Wave Electrode (AE02-60); Wave Electrode (AE02-50) received FDA 510(k) clearance on 2025-01-02, under approval number K242326.

What company makes Wave Electrode (AE02-60); Wave Electrode (AE02-50)?

Wave Electrode (AE02-60); Wave Electrode (AE02-50) is manufactured by Bionit Labs Srl.

What is the FDA product code for Wave Electrode (AE02-60); Wave Electrode (AE02-50)?

The FDA product code for Wave Electrode (AE02-60); Wave Electrode (AE02-50) is GXY.

Other Devices by Bionit Labs Srl

K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)

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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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