VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)— 510(k) K053027

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K053027 for VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300), Substantially Equivalent on 2005-11-22. Applicant: Welch Allyn, Inc..

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2005-10-27
Decision date: 2005-11-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Skaneateles Falls, NY, US

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Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.