MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1— 510(k) K091040
Substantially EquivalentMicrolife Intellectual Property GmbH
FDA 510(k) clearance K091040 for MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1, Substantially Equivalent on 2009-05-13. Applicant: Microlife Intellectual Property GmbH.
Clearance details
- Applicant
- Microlife Intellectual Property GmbH
- Product code
- Code FLL
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, 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.