DISPOSABLE ECG ELECTRODE— 510(k) K953649

Substantially Equivalent

Kendall-Ltp

FDA 510(k) clearance K953649 for DISPOSABLE ECG ELECTRODE, Substantially Equivalent on 1996-06-21. Applicant: Kendall-Ltp.

Clearance details

Applicant: Kendall-Ltp
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1995-08-04
Decision date: 1996-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicopee, MA, US

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Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.