GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000— 510(k) K060649
Substantially EquivalentTyco Healthcare Group LP
FDA 510(k) clearance K060649 for GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000, Substantially Equivalent on 2006-05-22. Applicant: Tyco Healthcare Group LP.
Clearance details
- Applicant
- Tyco Healthcare Group LP
- Product code
- Code FLL
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, 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.