DeviceClearance

K093309

Substantially Equivalent

PRO-LINE CT (BASIC TRAY) MODEL MR28036101

Applicant
Medcomp ( Medical Components)
Product code
LJS
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Harleysville, PA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LJS

product code LJS
Death
31
Injury
2,791
Malfunction
18,374
Other
5
Total
21,201

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.