ORAL SLEEP DISORDER AID— 510(k) K991209

Substantially Equivalent

Perl-Rad Sleep Disorder Lab

FDA 510(k) clearance K991209 for ORAL SLEEP DISORDER AID, Substantially Equivalent on 1999-09-22. Applicant: Perl-Rad Sleep Disorder Lab.

Clearance details

Applicant: Perl-Rad Sleep Disorder Lab
Product code: Code LRK
Advisory panel: Dental
Date received: 1999-04-09
Decision date: 1999-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, CA, US

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.