TDK ECG ELECTRODE MEL-08-09 & -11— 510(k) K854596

Substantially Equivalent

Tdk Corp.

FDA 510(k) clearance K854596 for TDK ECG ELECTRODE MEL-08-09 & -11, Substantially Equivalent on 1986-05-07. Applicant: Tdk Corp..

Clearance details

Applicant: Tdk Corp.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1985-11-18
Decision date: 1986-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 272 01, Japan, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.