ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM— 510(k) K123361

Substantially Equivalent

Fiab Spa

FDA 510(k) clearance K123361 for ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM, Substantially Equivalent on 2013-02-27. Applicant: Fiab Spa.

Clearance details

Applicant: Fiab Spa
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2012-10-31
Decision date: 2013-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Firenze, IT

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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.