AIR Recon DL
K-Number: K213717 · 2022-06-08
Decision Date2022-06-08
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
AIR Recon DL is a medical device manufactured by Ge Medical Systems,Llc (Ge Healthcare). It received FDA 510(k) clearance on 2022-06-08 under approval number K213717. 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 2022-06-08. It is manufactured by Ge Medical Systems,Llc (Ge Healthcare). The 510(k) number is K213717.
When was AIR Recon DL approved by the FDA?
AIR Recon DL received FDA 510(k) clearance on 2022-06-08, under approval number K213717.
What company makes AIR Recon DL?
AIR Recon DL is manufactured by Ge Medical Systems,Llc (Ge Healthcare).
What is the FDA product code for AIR Recon DL?
The FDA product code for AIR Recon DL is LNH.
Other Devices by Ge Medical Systems,Llc (Ge Healthcare)
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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.