TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE)— 510(k) K874437

Substantially Equivalent

Labeltape Meditect, Inc.

FDA 510(k) clearance K874437 for TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE), Substantially Equivalent on 1987-12-30. Applicant: Labeltape Meditect, Inc..

Clearance details

Applicant: Labeltape Meditect, Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1987-10-28
Decision date: 1987-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, 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.