MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM— 510(k) K022453

Substantially Equivalent

Welch Allyn Protocol, Inc.

FDA 510(k) clearance K022453 for MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM, Substantially Equivalent on 2002-08-21. Applicant: Welch Allyn Protocol, Inc..

Clearance details

Applicant: Welch Allyn Protocol, Inc.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2002-07-26
Decision date: 2002-08-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Beaverton, OR, US

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Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.