12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200— 510(k) K050074

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K050074 for 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200, Substantially Equivalent on 2005-03-22. Applicant: Welch Allyn, Inc..

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2005-01-12
Decision date: 2005-03-22
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Skaneateles Falls, NY, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.