MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE— 510(k) K130290
Substantially EquivalentIntel-Ge Care Innovations, LLC
FDA 510(k) clearance K130290 for MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE, Substantially Equivalent on 2013-06-04. Applicant: Intel-Ge Care Innovations, LLC.
Clearance details
- Applicant
- Intel-Ge Care Innovations, LLC
- Product code
- Code DRG
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roseville, CA, US
Adverse events under product code DRG
product code DRG- Death
- 5
- Total
- 5
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.