DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE— 510(k) K051422

Substantially Equivalent

Medisim, Ltd.

FDA 510(k) clearance K051422 for DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE, Substantially Equivalent on 2005-09-01. Applicant: Medisim, Ltd..

Clearance details

Applicant: Medisim, Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2005-06-01
Decision date: 2005-09-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Kfar Saba, IL

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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.