510(k) K250058
K250058 is an FDA 510(k) premarket notification submitted by Brain Electrophysiology Laboratory Company, LLC for the device "NEAT 001". The FDA issued a decision of Substantially Equivalent on April 10, 2025. The device falls under product code OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Brain Electrophysiology Laboratory Company, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2025
- Date Received
- January 10, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automatic Event Detection Software For Polysomnograph With Electroencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user