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FDA 510(k)

airVata™

K-Number: K240427 · 2024-02-14

Decision Date2024-02-14
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

airVata™ is a medical device manufactured by Gelb Practice Solutions, Inc.. It received FDA 510(k) clearance on 2024-02-14 under approval number K240427. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the airVata™?

airVata™ is a medical device that received FDA 510(k) clearance on 2024-02-14. It is manufactured by Gelb Practice Solutions, Inc.. The 510(k) number is K240427.

When was airVata™ approved by the FDA?

airVata™ received FDA 510(k) clearance on 2024-02-14, under approval number K240427.

What company makes airVata™?

airVata™ is manufactured by Gelb Practice Solutions, Inc..

What is the FDA product code for airVata™?

The FDA product code for airVata™ is LRK.

Related Devices (Code: LRK)

Official Source

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