NF-50-E DISPOSABLE ECG ELECTRODE— 510(k) K902407

Name: FDA 510(k) clearance K902407
Creator: U.S. Food and Drug Administration
Published: 1990-07-31

Substantially Equivalent

Medicotest, Inc.

FDA 510(k) clearance K902407 for NF-50-E DISPOSABLE ECG ELECTRODE, Substantially Equivalent on 1990-07-31. Applicant: Medicotest, Inc.. Device class: 2.

Clearance details

Applicant: Medicotest, Inc.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1990-05-31
Decision date: 1990-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRX

view all

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 Medicotest, Inc.

view all

K983597 — NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES1999-01-11
K970639 — NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K1997-05-15
K961643 — MEDICOTEST ECG ELECTRODES1996-12-09
K952176 — DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K1995-09-25
K941568 — K-10-VS, DA-05-VS, RECORDING ELECTRODES1994-11-04

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.