FDA 510(k)

NeurotriS (SX2500); NeurotriS (SX3800)

K-Number: K251909 · 2025-09-03

Decision Date2025-09-03

Product CodeNFO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NeurotriS (SX2500); NeurotriS (SX3800) is a medical device manufactured by A-1 Engineering. It received FDA 510(k) clearance on 2025-09-03 under approval number K251909. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeurotriS (SX2500); NeurotriS (SX3800)?

NeurotriS (SX2500); NeurotriS (SX3800) is a medical device that received FDA 510(k) clearance on 2025-09-03. It is manufactured by A-1 Engineering. The 510(k) number is K251909.

When was NeurotriS (SX2500); NeurotriS (SX3800) approved by the FDA?

NeurotriS (SX2500); NeurotriS (SX3800) received FDA 510(k) clearance on 2025-09-03, under approval number K251909.

What company makes NeurotriS (SX2500); NeurotriS (SX3800)?

NeurotriS (SX2500); NeurotriS (SX3800) is manufactured by A-1 Engineering.

What is the FDA product code for NeurotriS (SX2500); NeurotriS (SX3800)?

The FDA product code for NeurotriS (SX2500); NeurotriS (SX3800) is NFO.

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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.