510(k) K922344— OMRON TYMPANIC THERMOMETER MC-500

Substantially Equivalent

Omron Healthcare, Inc.

Clearance details

Applicant: Omron Healthcare, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1992-05-19
Decision date: 1993-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, 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.