DeviceClearance

K894699

Substantially Equivalent

TYPE 9140 (SYSTEM ATHENA)

Applicant
S & W Medico Teknik
Product code
DRT
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Denmark, DK
Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT
Death
4
Total
4

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.