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510(k) clearances

Neurora

Argus Cognitive, Inc. · Neurology

K260064Substantially EquivalentTraditionalQPF
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Third party flag
N
City
Hanover
Advisory committee description
Neurology
Address 1
35 S. Main St.
Statement or summary
Summary
Product code
QPF
Zip code
03755
Applicant
Argus Cognitive, Inc.
Decision date
2026-10-02
Decision code
SESE
Country code
US
Device name
Neurora
Advisory committee
NE
Contact
Andrea Marosan
K number
K260064
State
NH
Date received
2026-01-09
Review advisory committee
NE
Postal code
03755
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Pediatric Autism Spectrum Disorder Diagnosis Aid
Medical specialty description
Neurology
Regulation number
882.1491
Device class
2
Registration number
3020832299, 3027553518
FEI number
3020832299, 3027553518
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.