FDA 510(k)

NEAT 001

K-Number: K250058 · 2025-04-10

ApplicantBrain Electrophysiology Laboratory Company, LLC

Decision Date2025-04-10

Product CodeOLZ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NEAT 001 is the device name listed in this FDA 510(k) record. The listed applicant is Brain Electrophysiology Laboratory Company, LLC. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K250058. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEAT 001?

NEAT 001 is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is Brain Electrophysiology Laboratory Company, LLC. The 510(k) number is K250058.

When did NEAT 001 receive FDA 510(k) clearance?

NEAT 001 received FDA 510(k) clearance on 2025-04-10, under 510(k) number K250058.

Who is the listed applicant for NEAT 001?

The FDA 510(k) record lists Brain Electrophysiology Laboratory Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEAT 001?

The FDA product code for NEAT 001 is OLZ.

Other records listing Brain Electrophysiology Laboratory Company, LLC 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.

K241513Sourcerer

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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.