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)

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 the device name listed in this FDA 510(k) record. The listed applicant is Zelegent, Inc.. It received FDA 510(k) clearance on 2018-12-06 under 510(k) 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. The listed applicant is Zelegent, Inc.. The 510(k) number is K181107.

When did Elevo® Kit Snoring Intervention Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Elevo® Kit Snoring Intervention Device?

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

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

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

Other records listing Zelegent, Inc. as applicant

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.

K213475Elevo Snoring Intervention Set

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.

↑