DISPOSABLE CONCENTRIC NEEDLE ELECTRODE— 510(k) K924521

Name: FDA 510(k) clearance K924521
Creator: U.S. Food and Drug Administration
Published: 1993-02-12

Substantially Equivalent

Chalgren Enterprises, Inc.

FDA 510(k) clearance K924521 for DISPOSABLE CONCENTRIC NEEDLE ELECTRODE, Substantially Equivalent on 1993-02-12. Applicant: Chalgren Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Chalgren Enterprises, Inc.
Product code: Code IKT
Device class: Class 2
Regulation: 21 CFR 890.1385
Advisory panel: Physical Medicine
Date received: 1992-09-08
Decision date: 1993-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gilroy, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IKT

view all

K253581 — Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001) +5 more2026-03-15
K173815 — Allergan Botox Needle Electrode2018-06-29
K161430 — Myoject Luer Lock Needle Electrode2017-03-02
K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes2016-06-03
K143433 — Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm2015-08-28

More clearances from Chalgren Enterprises, Inc.

view all

K982950 — FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-5501999-06-22
K960591 — RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP1996-06-13
K955335 — DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE1996-01-29
K953354 — EMG DISC RECORDING ELECTRODE1996-01-22
K953356 — EMG RECORDING RING ELECTRODE1996-01-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.