CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER— 510(k) K050463
Substantially EquivalentTaidoc Technology Corporation
FDA 510(k) clearance K050463 for CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER, Substantially Equivalent on 2005-07-27. 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
- Traditional
- Location
- San Chung, Taipei, TW
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More clearances from Taidoc Technology Corporation
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- 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.