Elevo® Kit Snoring Intervention Device

Device, Anti-snoring

Zelegent, Inc.

The following data is part of a premarket notification filed by Zelegent, Inc. with the FDA for Elevo® Kit Snoring Intervention Device.

Pre-market Notification Details

• Device ID: K181107
• 510k Number: K181107
• Device Name: Elevo® Kit Snoring Intervention Device
• Classification: Device, Anti-snoring
• Applicant: Zelegent, Inc. 5151 California Avenue Irvine, CA 92617
• Contact: David C. Humbert
• Correspondent: David C. Humbert; Zelegent, Inc. 5151 California Avenue Irvine, CA 92617
• Product Code: LRK
• CFR Regulation Number: 872.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-04-26
• Decision Date: 2018-12-06
• Summary: summary