U-RIGHT TD-1240 THERMOMETER— 510(k) K113159
Substantially EquivalentTaidoc Technology Corporation
FDA 510(k) clearance K113159 for U-RIGHT TD-1240 THERMOMETER, Substantially Equivalent on 2012-01-06. Applicant: Taidoc Technology Corporation. Device class: 2.
Clearance details
- Applicant
- Taidoc Technology Corporation
- 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
- New Taipei City, TW
Recent devices under product code FLL
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- K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
- K250470 — Ear Thermometer (3 models)
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- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
More clearances from Taidoc Technology Corporation
view all- K221349 — XPER Technology PREMIUM Pro Blood Glucose Monitoring System
- K201037 — FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
- K200946 — Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)
- K190579 — TD-4183 Blood Glucose Monitoring System
- K182934 — FORA P100 Blood Pressure Monitoring System
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.