U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118— 510(k) K100942
Substantially EquivalentTaidoc Technology Corporation
FDA 510(k) clearance K100942 for U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118, Substantially Equivalent on 2010-05-26. 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
- Taipei County, TW
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More clearances from Taidoc Technology Corporation
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- 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.