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510(k) K973529

NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES by Medicotest A/S — Product Code IKT

K973529 is an FDA 510(k) premarket notification submitted by Medicotest A/S for the device "NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES". The FDA issued a decision of Substantially Equivalent on November 20, 1997. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Medicotest A/S has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1997
Date Received
September 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle, Diagnostic Electromyograph
Device Class
Class II
Regulation Number
890.1385
Review Panel
NE
Submission Type

Other clearances by Medicotest A/S

  • K020382 — BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA (June 28, 2002)
  • K020907 — NEUROLINE, SUBDERMAL NEEDLE ELECTRODES (June 14, 2002)
  • K002079 — MULTI-FUNCTION DEFIBRILLATION ELECTRODE (February 22, 2001)
  • K001869 — DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE (September 18, 2000)
  • K983689 — BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES (January 15, 1999)
  • K983597 — NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES (January 11, 1999)
  • K970639 — NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010 (May 15, 1997)
  • K965194 — MEDICOM, TENS ELECTRODES (March 6, 1997)
  • K961643 — MEDICOTEST ECG ELECTRODES (December 9, 1996)
  • K952176 — DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K (September 25, 1995)

Other clearances for product code IKT

  • K253581 — Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable (March 15, 2026)
  • K173815 — Allergan Botox Needle Electrode (June 29, 2018)
  • K161430 — Myoject Luer Lock Needle Electrode (March 2, 2017)
  • K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, (June 3, 2016)
  • K143433 — Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable C (August 28, 2015)
  • K120342 — EMG RECORDING ELECTRODE ASSEMBLY (June 22, 2012)
  • K112034 — TECA ELITE DISPOSABLE CONCENTRIC NEEDLES (August 12, 2011)
  • K111131 — TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES (June 17, 2011)
  • K092973 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR N (October 7, 2010)
  • K093825 — AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE (January 13, 2010)

FDA data resources