Pascall Sensor Unit (PSU1)— 510(k) K254213
Substantially EquivalentPascall Systems, Inc.
FDA 510(k) clearance K254213 for Pascall Sensor Unit (PSU1), Substantially Equivalent on 2026-08-19. Applicant: Pascall Systems, Inc.. Device class: 2.
Summary
Pascall Systems filed the Pascall Sensor Unit, model PSU1, under product code OLT, non-normalizing quantitative electroencephalograph software. The record has no description beyond the name and that code name.
Class II, 21 CFR 882.1400. Neurology is both the classification panel and the review panel, and the submission type is Special.
Pascall filed from Cambridge, Massachusetts. Review took 233 calendar days (December 29, 2025 to August 19, 2026) and ended in a substantially equivalent decision.
Clearance details
- Applicant
- Pascall Systems, Inc.
- Product code
- Product code OLT
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cambridge, MA, US
Recent devices under product code OLT
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view allAdverse events under product code OLT
product code OLT- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.