K130821

Substantially Equivalent

INTEL-GE CARE INNOVATIONS CONNECT RCM

Applicant: Intel-Ge Care Innovations, LLC
Product code: DRG
Advisory panel: Cardiovascular
Date received: 2013-03-25
Decision date: 2013-08-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Roseville, CA, US

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.