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FDA 510(k)

SafeAir combi (SFR-combi-US)

K-Number: K223932 · 2023-04-26

ApplicantLina Medical Aps
Decision Date2023-04-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SafeAir combi (SFR-combi-US) is a medical device manufactured by Lina Medical Aps. It received FDA 510(k) clearance on 2023-04-26 under approval number K223932. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SafeAir combi (SFR-combi-US)?

SafeAir combi (SFR-combi-US) is a medical device that received FDA 510(k) clearance on 2023-04-26. It is manufactured by Lina Medical Aps. The 510(k) number is K223932.

When was SafeAir combi (SFR-combi-US) approved by the FDA?

SafeAir combi (SFR-combi-US) received FDA 510(k) clearance on 2023-04-26, under approval number K223932.

What company makes SafeAir combi (SFR-combi-US)?

SafeAir combi (SFR-combi-US) is manufactured by Lina Medical Aps.

What is the FDA product code for SafeAir combi (SFR-combi-US)?

The FDA product code for SafeAir combi (SFR-combi-US) is GEI.

Other Devices by Lina Medical Aps

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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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