FLEXIBLE TIP THERMOMETER, MODEL 011206— 510(k) K030673
Substantially EquivalentGlobal Treasure Industries , Ltd.
FDA 510(k) clearance K030673 for FLEXIBLE TIP THERMOMETER, MODEL 011206, Substantially Equivalent on 2003-04-04. Applicant: Global Treasure Industries , Ltd..
Clearance details
- Applicant
- Global Treasure Industries , Ltd.
- Product code
- Code FLL
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly, MA, US
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.