DeviceClearance

K021439

Substantially Equivalent

MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO

Applicant
Animas Corp.
Product code
LZG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Frazer, PA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LZG

product code LZG
Death
104
Injury
12,022
Malfunction
135,004
Other
1
Total
147,131

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.