FDA 510(k)

Argus Cognitive ReVISION Software

K-Number: K223322 · 2023-07-24

Decision Date2023-07-24

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Argus Cognitive ReVISION Software 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 2023-07-24 under 510(k) number K223322. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Argus Cognitive ReVISION Software?

Argus Cognitive ReVISION Software is a medical device that received FDA 510(k) clearance on 2023-07-24. The listed applicant is Argus Cognitive, Inc.. The 510(k) number is K223322.

When did Argus Cognitive ReVISION Software receive FDA 510(k) clearance?

Argus Cognitive ReVISION Software received FDA 510(k) clearance on 2023-07-24, under 510(k) number K223322.

Who is the listed applicant for Argus Cognitive ReVISION Software?

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 Argus Cognitive ReVISION Software?

The FDA product code for Argus Cognitive ReVISION Software is LLZ.

Related Devices (Code: LLZ)

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Official Source

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