ATLAS MONITOR, MODELS 200,210,220— 510(k) K022084

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K022084 for ATLAS MONITOR, MODELS 200,210,220, Substantially Equivalent on 2002-09-26. Applicant: Welch Allyn, Inc..

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2002-06-27
Decision date: 2002-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Skaneateles Falls, NY, US

Download summary PDF View on FDA.gov ↗

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.