DeviceClearance

K122361

Substantially Equivalent

T:CONNECT DATA MANAGEMENT SYSTEM

Applicant
Tandem Diabetes Care, Inc.
Product code
OUG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OUG

product code OUG
Malfunction
2,311
Other
12
Total
2,323

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.