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FDA 510(k)

Neurora

K-Number: K260064 · 2026-10-02

ApplicantArgus Cognitive, Inc.
Decision Date2026-10-02
Product CodeQPF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neurora is the device name listed in this FDA 510(k) record. The listed applicant is Argus Cognitive, Inc.. It received FDA 510(k) clearance on 2026-10-02 under 510(k) number K260064. The device is classified under product code QPF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neurora?

Neurora is a medical device that received FDA 510(k) clearance on 2026-10-02. The listed applicant is Argus Cognitive, Inc.. The 510(k) number is K260064.

When did Neurora receive FDA 510(k) clearance?

Neurora received FDA 510(k) clearance on 2026-10-02, under 510(k) number K260064.

Who is the listed applicant for Neurora?

The FDA 510(k) record lists Argus Cognitive, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neurora?

The FDA product code for Neurora is QPF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Argus Cognitive, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251417ReVISION 2K223322Argus Cognitive ReVISION Software

Related Devices (Code: QPF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253442EarliPoint AssessmentEarlitec DiagnosticsK243558Canvas DxCognoa, Inc.K243891EarliPoint SystemEarlitec DiagnosticsK230337EarliPointEarlitec Diagnostics, Inc.K213882EarliPoint SystemEarlitec Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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