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FDA 510(k)

Elevo® Kit Snoring Intervention Device

K-Number: K181107 · 2018-12-06

ApplicantZelegent, Inc.
Decision Date2018-12-06
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Elevo® Kit Snoring Intervention Device is a medical device manufactured by Zelegent, Inc.. It received FDA 510(k) clearance on 2018-12-06 under approval number K181107. 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® Kit Snoring Intervention Device?

Elevo® Kit Snoring Intervention Device is a medical device that received FDA 510(k) clearance on 2018-12-06. It is manufactured by Zelegent, Inc.. The 510(k) number is K181107.

When was Elevo® Kit Snoring Intervention Device approved by the FDA?

Elevo® Kit Snoring Intervention Device received FDA 510(k) clearance on 2018-12-06, under approval number K181107.

What company makes Elevo® Kit Snoring Intervention Device?

Elevo® Kit Snoring Intervention Device is manufactured by Zelegent, Inc..

What is the FDA product code for Elevo® Kit Snoring Intervention Device?

The FDA product code for Elevo® Kit Snoring Intervention Device is LRK.

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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.

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