WEST BEND ELECTRIC THERMOMETER— 510(k) K851224

Substantially Equivalent

The West Bend Co.

FDA 510(k) clearance K851224 for WEST BEND ELECTRIC THERMOMETER, Substantially Equivalent on 1985-04-29. Applicant: The West Bend Co..

Clearance details

Applicant: The West Bend Co.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1985-03-26
Decision date: 1985-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Bend, WI, 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.