DeviceClearance

K220916

Substantially Equivalent

iLet® Dosing Decision Software

Applicant
Beta Bionics, Inc.
Product code
QJI
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Concord, MA, US
Download summary PDF View 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.