APNEARX— 510(k) K113569

Substantially Equivalent

Apnea Science Corporation

FDA 510(k) clearance K113569 for APNEARX, Substantially Equivalent on 2012-03-01. Applicant: Apnea Science Corporation.

Clearance details

Applicant: Apnea Science Corporation
Product code: Code LRK
Advisory panel: Dental
Date received: 2011-12-02
Decision date: 2012-03-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Aliso Viejo, 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.