DeviceClearance

K231160

Substantially Equivalent

Cardio Q50, Cardio Q70

Applicant
Bionet Co., Ltd.
Product code
DPS
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Seoul, KR
Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS
Death
7
Total
7

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.