K241411

Substantially Equivalent

Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)

Applicant: Welch Allyn, Inc.
Product code: MWI
Advisory panel: Cardiovascular
Date received: 2024-05-17
Decision date: 2024-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skaneateles Falls, NY, US

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.