DeviceClearance

K854133

Substantially Equivalent

BIO MEDICUS BIO CONSOLE 540

Applicant
Bio Medicus, Inc.
Product code
DWA
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Eden Prairie, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DWA

product code DWA
Death
15
Malfunction
1,654
Total
1,669

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.