K171529

Substantially Equivalent

Snorer's Friend

Applicant: Scope Healthcare Technologies Pty, Ltd.
Product code: LRK
Advisory panel: Dental
Date received: 2017-05-25
Decision date: 2018-01-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Unley, AU

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.