MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES— 510(k) K072108
Substantially EquivalentTecnimed 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.. Device class: 2.
Clearance details
- Applicant
- Tecnimed S.R.L.
- Product code
- Code FLL
- Device class
- Class 2
- Regulation
- 21 CFR 880.2910
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Great Neck, NY, US
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)
More clearances from Tecnimed S.R.L.
view allAdverse 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.