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FDA 510(k)

AIRAscore

K-Number: K223180 · 2023-08-25

ApplicantAiramed GmbH
Decision Date2023-08-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AIRAscore is a medical device manufactured by Airamed GmbH. It received FDA 510(k) clearance on 2023-08-25 under approval number K223180. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRAscore?

AIRAscore is a medical device that received FDA 510(k) clearance on 2023-08-25. It is manufactured by Airamed GmbH. The 510(k) number is K223180.

When was AIRAscore approved by the FDA?

AIRAscore received FDA 510(k) clearance on 2023-08-25, under approval number K223180.

What company makes AIRAscore?

AIRAscore is manufactured by Airamed GmbH.

What is the FDA product code for AIRAscore?

The FDA product code for AIRAscore is LLZ.

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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.

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