GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES— 510(k) K020418

Substantially Equivalent

P.T. Greenleaf

FDA 510(k) clearance K020418 for GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES, Substantially Equivalent on 2003-04-29. Applicant: P.T. Greenleaf.

Clearance details

Applicant: P.T. Greenleaf
Product code: Code MEA
Advisory panel: General Hospital
Date received: 2002-02-07
Decision date: 2003-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perth, AU

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Adverse events under product code MEA

product code MEA

Death: 19
Malfunction: 25,089
Total: 25,108

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.