FMT Reusable Temperature Probes— 510(k) K213100
Substantially EquivalentMetko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti
FDA 510(k) clearance K213100 for FMT Reusable Temperature Probes, Substantially Equivalent on 2023-07-18. Applicant: Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti.
Clearance details
- Applicant
- Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti
- Product code
- Code FLL
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yenimahalle - Ankara, TR
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.