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FDA 510(k)

Nelli (Version 7.11)

K-Number: K251506 · 2025-11-21

ApplicantNeuro Event Labs OY
Decision Date2025-11-21
Product CodePOS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nelli (Version 7.11) is a medical device manufactured by Neuro Event Labs OY. It received FDA 510(k) clearance on 2025-11-21 under approval number K251506. The device is classified under product code POS. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nelli (Version 7.11)?

Nelli (Version 7.11) is a medical device that received FDA 510(k) clearance on 2025-11-21. It is manufactured by Neuro Event Labs OY. The 510(k) number is K251506.

When was Nelli (Version 7.11) approved by the FDA?

Nelli (Version 7.11) received FDA 510(k) clearance on 2025-11-21, under approval number K251506.

What company makes Nelli (Version 7.11)?

Nelli (Version 7.11) is manufactured by Neuro Event Labs OY.

What is the FDA product code for Nelli (Version 7.11)?

The FDA product code for Nelli (Version 7.11) is POS.

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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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