TERPERATUR SENSING DEVICE— 510(k) K802607

Substantially Equivalent

Burditt & Calkins-Siemens-Elema

FDA 510(k) clearance K802607 for TERPERATUR SENSING DEVICE, Substantially Equivalent on 1980-11-19. Applicant: Burditt & Calkins-Siemens-Elema.

Clearance details

Applicant: Burditt & Calkins-Siemens-Elema
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1980-10-21
Decision date: 1980-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.