Elevo Snoring Intervention Set
K-Number: K213475 · 2022-01-27
ApplicantZelegent, Inc.
Decision Date2022-01-27
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Elevo Snoring Intervention Set is a medical device manufactured by Zelegent, Inc.. It received FDA 510(k) clearance on 2022-01-27 under approval number K213475. 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 Elevo Snoring Intervention Set?
Elevo Snoring Intervention Set is a medical device that received FDA 510(k) clearance on 2022-01-27. It is manufactured by Zelegent, Inc.. The 510(k) number is K213475.
When was Elevo Snoring Intervention Set approved by the FDA?
Elevo Snoring Intervention Set received FDA 510(k) clearance on 2022-01-27, under approval number K213475.
What company makes Elevo Snoring Intervention Set?
Elevo Snoring Intervention Set is manufactured by Zelegent, Inc..
What is the FDA product code for Elevo Snoring Intervention Set?
The FDA product code for Elevo Snoring Intervention Set is LRK.
Related Clinical Trials
Other Devices by Zelegent, Inc.
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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.