ANTI-SNORING / SLEEP APNEA DEVICE— 510(k) K061688

Substantially Equivalent

Tomed Dr. Toussaint GmbH

FDA 510(k) clearance K061688 for ANTI-SNORING / SLEEP APNEA DEVICE, Substantially Equivalent on 2006-09-08. Applicant: Tomed Dr. Toussaint GmbH.

Clearance details

Applicant: Tomed Dr. Toussaint GmbH
Product code: Code LRK
Advisory panel: Dental
Date received: 2006-06-15
Decision date: 2006-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bensheim, DE

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.