510(k) K261962— SmartGuard Technology; Predictive Low Glucose Technology

Substantially Equivalent

Medtronic MiniMed

Clearance details

Applicant
Medtronic MiniMed
Product code
Code QJI
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Northridge, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code QJI

product code QJI
Other
3
Total
3

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.