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FDA 510(k)

Pixyl.Neuro

K-Number: K213253 · 2023-06-30

ApplicantPixyl SA
Decision Date2023-06-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Pixyl.Neuro is a medical device manufactured by Pixyl SA. It received FDA 510(k) clearance on 2023-06-30 under approval number K213253. 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 Pixyl.Neuro?

Pixyl.Neuro is a medical device that received FDA 510(k) clearance on 2023-06-30. It is manufactured by Pixyl SA. The 510(k) number is K213253.

When was Pixyl.Neuro approved by the FDA?

Pixyl.Neuro received FDA 510(k) clearance on 2023-06-30, under approval number K213253.

What company makes Pixyl.Neuro?

Pixyl.Neuro is manufactured by Pixyl SA.

What is the FDA product code for Pixyl.Neuro?

The FDA product code for Pixyl.Neuro 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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