DeviceClearance

K002434

Substantially Equivalent

PALM PUMP

Applicant
Sorenson Medical, Inc.
Product code
MEA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
West Jordan, UT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MEA

product code MEA
Death
19
Malfunction
25,089
Total
25,108

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.