TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5— 510(k) K882904

Substantially Equivalent

Tdk Corp.

FDA 510(k) clearance K882904 for TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5, Substantially Equivalent on 1988-10-05. Applicant: Tdk Corp..

Clearance details

Applicant: Tdk Corp.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1988-07-12
Decision date: 1988-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 272 01, Japan, JP

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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.