510(k) K051233— OMRON MODEL 514N TYMPANIC THERMOMETER

Substantially Equivalent

Omron Healthcare, Inc.

Clearance details

Applicant: Omron Healthcare, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2005-05-13
Decision date: 2005-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Bonita Springs, FL, US

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.