MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE— 510(k) K022677

Substantially Equivalent

Alaris Medical Systems, Inc.

FDA 510(k) clearance K022677 for MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE, Substantially Equivalent on 2002-09-11. Applicant: Alaris Medical Systems, Inc..

Clearance details

Applicant: Alaris Medical Systems, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2002-08-12
Decision date: 2002-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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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.