K915270

Substantially Equivalent

PATIENT CONTROLLED SYRINGE PUMP TYPE 3300

Applicant
Graseby Medical , Ltd.
Product code
MEA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Watford, Herts., GB
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.