GEON DIGITAL CLINICAL THERMOMETER— 510(k) K003223

Substantially Equivalent

Geon Corp.

FDA 510(k) clearance K003223 for GEON DIGITAL CLINICAL THERMOMETER, Substantially Equivalent on 2001-01-12. Applicant: Geon Corp..

Clearance details

Applicant: Geon Corp.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2000-10-16
Decision date: 2001-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flaggstaff, AZ, US

Download summary PDF View on FDA.gov ↗

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.