FMT Disposable and Autoclavable Temperature Probes— 510(k) K240223

Substantially Equivalent

Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi

FDA 510(k) clearance K240223 for FMT Disposable and Autoclavable Temperature Probes, Substantially Equivalent on 2024-10-25. Applicant: Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi.

Clearance details

Applicant
Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi
Product code
Code FLL
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Yenimahalle-Ankara, TR
Download summary PDFView on FDA.gov ↗

Adverse events under product code FLL

product code FLL
Death
3
Malfunction
557
Total
560

Source: openFDA MAUDE database, through . 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.