FDA 510(k)

NeuroField Analysis Suite

K-Number: K240420 · 2024-09-20

Decision Date2024-09-20

Product CodeOLU

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NeuroField Analysis Suite is the device name listed in this FDA 510(k) record. The listed applicant is Neurofield, Inc.. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K240420. The device is classified under product code OLU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroField Analysis Suite?

NeuroField Analysis Suite is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Neurofield, Inc.. The 510(k) number is K240420.

When did NeuroField Analysis Suite receive FDA 510(k) clearance?

NeuroField Analysis Suite received FDA 510(k) clearance on 2024-09-20, under 510(k) number K240420.

Who is the listed applicant for NeuroField Analysis Suite?

The FDA 510(k) record lists Neurofield, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuroField Analysis Suite?

The FDA product code for NeuroField Analysis Suite is OLU.

Other records listing Neurofield, Inc. 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.

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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.