FDA 510(k)

AIR Recon DL

K-Number: K252379 · 2025-12-23

Decision Date2025-12-23

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AIR Recon DL is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2025-12-23 under approval number K252379. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR Recon DL?

AIR Recon DL is a medical device that received FDA 510(k) clearance on 2025-12-23. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K252379.

When was AIR Recon DL approved by the FDA?

AIR Recon DL received FDA 510(k) clearance on 2025-12-23, under approval number K252379.

What company makes AIR Recon DL?

AIR Recon DL is manufactured by Ge Medical Systems, LLC.

What is the FDA product code for AIR Recon DL?

The FDA product code for AIR Recon DL is LNH.

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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.