510(k) clearance
Pascall Sensor Unit (PSU1)
- 510(k) number
- K254213
- Applicant
- Pascall Systems, Inc.
- Decision date
- Aug 19, 2026
- Date received
- Dec 29, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- OLT
- Device type
- Non-Normalizing Quantitative Electroencephalograph Software
- Device class
- Class II
- Regulation
- 21 CFR 882.1400
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Cambridge, MA, US