MEDLEY PCA MODULE, MODEL 8120— 510(k) K032233

Substantially Equivalent

Alaris Medical Systems, Inc.

FDA 510(k) clearance K032233 for MEDLEY PCA MODULE, MODEL 8120, Substantially Equivalent on 2003-09-09. Applicant: Alaris Medical Systems, Inc..

Clearance details

Applicant: Alaris Medical Systems, Inc.
Product code: Code MEA
Advisory panel: General Hospital
Date received: 2003-07-21
Decision date: 2003-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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, 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.