Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)— 510(k) K240077
Substantially EquivalentCovidien
FDA 510(k) clearance K240077 for Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044), Substantially Equivalent on 2024-08-20. Applicant: Covidien. Device class: 2.
Clearance details
- Applicant
- Covidien
- 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
- Boulder, CO, US
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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.