Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

airVata™

K-Number: K240427 · 2024-02-14

ApplicantGelb Practice Solutions, Inc.
Decision Date2024-02-14
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

airVata™ is the device name listed in this FDA 510(k) record. The listed applicant is Gelb Practice Solutions, Inc.. It received FDA 510(k) clearance on 2024-02-14 under 510(k) 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. The listed applicant is Gelb Practice Solutions, Inc.. The 510(k) number is K240427.

When did airVata™ receive FDA 510(k) clearance?

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

Who is the listed applicant for airVata™?

The FDA 510(k) record lists Gelb Practice Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for airVata™?

The FDA product code for airVata™ is LRK.

Related Devices (Code: LRK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

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.

↑