EWC: ECG II CABLE LEADWIRE SYSTEM— 510(k) K984263

Substantially Equivalent

Ewc

FDA 510(k) clearance K984263 for EWC: ECG II CABLE LEADWIRE SYSTEM, Substantially Equivalent on 1999-02-02. Applicant: Ewc.

Clearance details

Applicant: Ewc
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 1998-11-30
Decision date: 1999-02-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
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.