NEAT 001
K-Number: K250058 · 2025-04-10
Decision Date2025-04-10
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
NEAT 001 is a medical device manufactured by Brain Electrophysiology Laboratory Company, LLC. It received FDA 510(k) clearance on 2025-04-10 under approval 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. It is manufactured by Brain Electrophysiology Laboratory Company, LLC. The 510(k) number is K250058.
When was NEAT 001 approved by the FDA?
NEAT 001 received FDA 510(k) clearance on 2025-04-10, under approval number K250058.
What company makes NEAT 001?
NEAT 001 is manufactured by Brain Electrophysiology Laboratory Company, LLC.
What is the FDA product code for NEAT 001?
The FDA product code for NEAT 001 is OLZ.
Other Devices by Brain Electrophysiology Laboratory Company, LLC
Related Devices (Code: OLZ)
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.