Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)— 510(k) K210014
Substantially EquivalentGuandong Genial Technology Co., Limited
FDA 510(k) clearance K210014 for Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85), Substantially Equivalent on 2021-06-04. Applicant: Guandong Genial Technology Co., Limited. Device class: 2.
Clearance details
- Applicant
- Guandong Genial Technology Co., Limited
- 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
- Traditional
- Location
- Zhaoqing, CN
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.