Neurora— 510(k) K260064
Substantially EquivalentArgus Cognitive, Inc.
FDA 510(k) clearance K260064 for Neurora, Substantially Equivalent on 2026-10-02. Applicant: Argus Cognitive, Inc.. Device class: 2.
Summary
Neurora from Argus Cognitive is filed under QPF, pediatric autism spectrum disorder diagnosis aids. The record doesn't describe how the device works or what inputs it uses.
Class II, 21 CFR 882.1491. The Neurology panel reviewed it as a Traditional 510(k).
Argus Cognitive filed from Hanover, New Hampshire. Review took 266 days (January 9 to October 2, 2026).
Clearance details
- Applicant
- Argus Cognitive, Inc.
- Product code
- Product code QPF
- Device class
- Class 2
- Regulation
- 21 CFR 882.1491
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hanover, NH, US
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