TDK ECG ELECTRODE, MEL-10L— 510(k) K883643

Name: FDA 510(k) clearance K883643
Creator: U.S. Food and Drug Administration
Published: 1988-11-17

Substantially Equivalent

Tdk Corp.

FDA 510(k) clearance K883643 for TDK ECG ELECTRODE, MEL-10L, Substantially Equivalent on 1988-11-17. Applicant: Tdk Corp.. Device class: 2.

Clearance details

Applicant: Tdk Corp.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1988-08-23
Decision date: 1988-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 272 01, Japan, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRX

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K171244 — Physiotrace2017-08-23
K140096 — HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE2014-07-24
K123658 — BIOMODULE 3-M12013-04-24
K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES2010-07-22
K101685 — IP-SET2010-07-01

More clearances from Tdk Corp.

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K882904 — TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-51988-10-05
K870834 — TDK ECG ELECTRODE MEL-101987-03-23
K863369 — MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES1987-01-06
K854596 — TDK ECG ELECTRODE MEL-08-09 & -111986-05-07
K833899 — TDK ECG ELECTRODE MEL-081984-02-10

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.