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FDA 510(k)

SwiftMR

K-Number: K253775 · 2026-03-26

ApplicantAirs Medical, Inc.
Decision Date2026-03-26
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SwiftMR is a medical device manufactured by Airs Medical, Inc.. It received FDA 510(k) clearance on 2026-03-26 under approval number K253775. 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 SwiftMR?

SwiftMR is a medical device that received FDA 510(k) clearance on 2026-03-26. It is manufactured by Airs Medical, Inc.. The 510(k) number is K253775.

When was SwiftMR approved by the FDA?

SwiftMR received FDA 510(k) clearance on 2026-03-26, under approval number K253775.

What company makes SwiftMR?

SwiftMR is manufactured by Airs Medical, Inc..

What is the FDA product code for SwiftMR?

The FDA product code for SwiftMR is QIH.

Other Devices by Airs Medical, Inc.

K210999SwiftMR K220416SwiftMR K230854SwiftMR K251483SwiftSight-Brain

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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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