DeviceClearance

K162108

Substantially Equivalent

Pressio 2 ICP Monitoring System

Applicant
Sophysa SA
Product code
GWM
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Orsay, FR
Download summary PDF View on FDA.gov ↗

Adverse events under product code GWM

product code GWM
Death
21
Injury
732
Malfunction
2,063
Other
1
Total
2,817

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.