MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES— 510(k) K072108

Substantially Equivalent

Tecnimed S.R.L.

FDA 510(k) clearance K072108 for MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES, Substantially Equivalent on 2007-08-31. Applicant: Tecnimed S.R.L..

Clearance details

Applicant: Tecnimed S.R.L.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2007-08-01
Decision date: 2007-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Great Neck, NY, US

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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.