DeviceClearance

K142336

Substantially Equivalent

GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System

Applicant
Arkray Factory, Inc.
Product code
CGA
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Koka-Shi, JP
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.