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FDA 510(k)

Strain AI (SAI001)

K-Number: K242359 · 2024-11-20

ApplicantExo, Inc.
Decision Date2024-11-20
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Strain AI (SAI001) is a medical device manufactured by Exo, Inc.. It received FDA 510(k) clearance on 2024-11-20 under approval number K242359. 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 Strain AI (SAI001)?

Strain AI (SAI001) is a medical device that received FDA 510(k) clearance on 2024-11-20. It is manufactured by Exo, Inc.. The 510(k) number is K242359.

When was Strain AI (SAI001) approved by the FDA?

Strain AI (SAI001) received FDA 510(k) clearance on 2024-11-20, under approval number K242359.

What company makes Strain AI (SAI001)?

Strain AI (SAI001) is manufactured by Exo, Inc..

What is the FDA product code for Strain AI (SAI001)?

The FDA product code for Strain AI (SAI001) is QIH.

Other Devices by Exo, Inc.

K232501AI Platform (AIP001) K230497Bladder AI (AIBV01) 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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