Sleep Analysis Module— 510(k) K261521
Substantially EquivalentNeurotronics, LLC
FDA 510(k) clearance K261521 for Sleep Analysis Module, Substantially Equivalent on 2026-10-09. Applicant: Neurotronics, LLC. Device class: 2.
Summary
Neurotronics' Sleep Analysis Module is filed under OLZ, automatic event detection software for polysomnographs with electroencephalograph. The device name is generic, and the record doesn't say which sleep events it detects or which recording systems it works with.
Class II, 21 CFR 882.1400. The Neurology panel reviewed it as a Traditional 510(k).
Neurotronics filed from Alachua, Florida. Review took 155 days (May 7 to October 9, 2026).
Clearance details
- Applicant
- Neurotronics, LLC
- Product code
- Product code OLZ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alachua, FL, US
Recent devices under product code OLZ
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