EWC: ECG CABLE AND LEADWIRE SYSTEMS— 510(k) K982817

Substantially Equivalent

Ewc

FDA 510(k) clearance K982817 for EWC: ECG CABLE AND LEADWIRE SYSTEMS, Substantially Equivalent on 1998-09-23. Applicant: Ewc.

Clearance details

Applicant: Ewc
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 1998-08-11
Decision date: 1998-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pewaukee, WI, US

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Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.