Somnowell Mandibular Advancement Appliance (MAA)— 510(k) K150941

Substantially Equivalent

Somnowell , Ltd.

FDA 510(k) clearance K150941 for Somnowell Mandibular Advancement Appliance (MAA), Substantially Equivalent on 2015-05-22. Applicant: Somnowell , Ltd..

Clearance details

Applicant: Somnowell , Ltd.
Product code: Code LRK
Advisory panel: Dental
Date received: 2015-04-08
Decision date: 2015-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.