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FDA 510(k)

Bladder AI (AIBV01)

K-Number: K230497 · 2023-06-22

ApplicantExo, Inc.
Decision Date2023-06-22
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bladder AI (AIBV01) is a medical device manufactured by Exo, Inc.. It received FDA 510(k) clearance on 2023-06-22 under approval number K230497. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bladder AI (AIBV01)?

Bladder AI (AIBV01) is a medical device that received FDA 510(k) clearance on 2023-06-22. It is manufactured by Exo, Inc.. The 510(k) number is K230497.

When was Bladder AI (AIBV01) approved by the FDA?

Bladder AI (AIBV01) received FDA 510(k) clearance on 2023-06-22, under approval number K230497.

What company makes Bladder AI (AIBV01)?

Bladder AI (AIBV01) is manufactured by Exo, Inc..

What is the FDA product code for Bladder AI (AIBV01)?

The FDA product code for Bladder AI (AIBV01) is QIH.

Other Devices by Exo, Inc.

K232501AI Platform (AIP001) K242359Strain AI (SAI001) K243239Lung AI (LAI001)

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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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