AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES— 510(k) K081160
Substantially EquivalentAvita Corporation
FDA 510(k) clearance K081160 for AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES, Substantially Equivalent on 2008-06-24. Applicant: Avita Corporation.
Clearance details
- Applicant
- Avita Corporation
- Product code
- Code FLL
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Flagstaff, AZ, 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.