DeviceClearance

K001604

Substantially Equivalent

DANA DIABECARE

Applicant
Sooil Development Co., Ltd.
Product code
LZG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Attleboro, MA, 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.