DeviceClearance

K113636

Substantially Equivalent

BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)

Applicant
Philosys Co., Ltd.
Product code
CGA
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New York, NY, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code CGA

product code CGA
Death
2
Malfunction
1,816
Total
1,818

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.