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FDA 510(k)

NeurotriS (SX2500); NeurotriS (SX3800)

K-Number: K251909 · 2025-09-03

ApplicantA-1 Engineering
Decision Date2025-09-03
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeurotriS (SX2500); NeurotriS (SX3800) is the device name listed in this FDA 510(k) record. The listed applicant is A-1 Engineering. It received FDA 510(k) clearance on 2025-09-03 under 510(k) 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. The listed applicant is A-1 Engineering. The 510(k) number is K251909.

When did NeurotriS (SX2500); NeurotriS (SX3800) receive FDA 510(k) clearance?

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

Who is the listed applicant for NeurotriS (SX2500); NeurotriS (SX3800)?

The FDA 510(k) record lists A-1 Engineering as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing A-1 Engineering 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.

K182440Body System

Related Devices (Code: NFO)

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

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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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