MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES— 510(k) K863369

Substantially Equivalent

Tdk Corp.

FDA 510(k) clearance K863369 for MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES, Substantially Equivalent on 1987-01-06. Applicant: Tdk Corp..

Clearance details

Applicant: Tdk Corp.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1986-07-24
Decision date: 1987-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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.