PRO-LINE CT (BASIC TRAY) MODEL MR28036101— 510(k) K093309

Substantially Equivalent

Medcomp ( Medical Components)

FDA 510(k) clearance K093309 for PRO-LINE CT (BASIC TRAY) MODEL MR28036101, Substantially Equivalent on 2009-11-24. Applicant: Medcomp ( Medical Components).

Clearance details

Applicant: Medcomp ( Medical Components)
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2009-10-22
Decision date: 2009-11-24
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, 2020-01-01 through 2026-04-23. 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.