omni TRAX Active Patient Tracker— 510(k) K143396
Substantially EquivalentCivco Medical Instruments CO Inc Dba Civco Medical Solutions
FDA 510(k) clearance K143396 for omni TRAX Active Patient Tracker, Substantially Equivalent on 2015-01-23. Applicant: Civco Medical Instruments CO Inc Dba Civco Medical Solutions.
Clearance details
- Applicant
- Civco Medical Instruments CO Inc Dba Civco Medical Solutions
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalona, IA, US
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.