DeviceClearance

K243639

Substantially Equivalent

Portare System (FA-001)

Applicant
Grumpy Innovation, Inc.
Product code
EOB
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sioux Falls, SD, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code EOB

product code EOB
Malfunction
6,143
Total
6,143

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.