PREGELLED INFANT DISPOSABLE ECG ELECTRODE— 510(k) K862756

Substantially Equivalent

Labeltape Meditect, Inc.

FDA 510(k) clearance K862756 for PREGELLED INFANT DISPOSABLE ECG ELECTRODE, Substantially Equivalent on 1986-08-06. Applicant: Labeltape Meditect, Inc..

Clearance details

Applicant: Labeltape Meditect, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1986-07-22
Decision date: 1986-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

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Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.