510(k) K010966— MEDLEY SP02 MODULE, MODEL 8220

Substantially Equivalent

Alaris Medical Systems, Inc.

Clearance details

Applicant: Alaris Medical Systems, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2001-04-02
Decision date: 2001-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.