510(k) clearance
Sleep Analysis Module
- 510(k) number
- K261521
- Applicant
- Neurotronics, LLC
- Decision date
- Oct 9, 2026
- Date received
- May 7, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OLZ
- Device type
- Automatic Event Detection Software For Polysomnograph With Electroencephalograph
- Device class
- Class II
- Regulation
- 21 CFR 882.1400
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Alachua, FL, US