ANTI-SNORING/SLEEP APNEA DEVICE— 510(k) K042161

Substantially Equivalent

Rj & VK Bird Pty , Ltd.

FDA 510(k) clearance K042161 for ANTI-SNORING/SLEEP APNEA DEVICE, Substantially Equivalent on 2004-10-27. Applicant: Rj & VK Bird Pty , Ltd..

Clearance details

Applicant: Rj & VK Bird Pty , Ltd.
Product code: Code LRK
Advisory panel: Dental
Date received: 2004-08-10
Decision date: 2004-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middle Park, Victoria, AU

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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.