FDA 510(k)

Strain AI (SAI001)

K-Number: K242359 · 2024-11-20

Decision Date2024-11-20

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Strain AI (SAI001) is the device name listed in this FDA 510(k) record. The listed applicant is Exo, Inc.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) 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. The listed applicant is Exo, Inc.. The 510(k) number is K242359.

When did Strain AI (SAI001) receive FDA 510(k) clearance?

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

Who is the listed applicant for Strain AI (SAI001)?

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

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

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

Other records listing Exo, 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.

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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.