FMT Disposable and Autoclavable Temperature Probes— 510(k) K240223
Substantially EquivalentMetko 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. Device class: 2.
Clearance details
- Applicant
- Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi
- Product code
- Product code FLL
- Device class
- Class 2
- Regulation
- 21 CFR 880.2910
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yenimahalle-Ankara, TR
Recent devices under product code FLL
view all- K253162 — Temperature probes (5 models)
- K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
- K250470 — Ear Thermometer (3 models)
- K243000 — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
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.