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510(k) K983597

NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES by Medicotest, Inc. — Product Code GXZ

K983597 is an FDA 510(k) premarket notification submitted by Medicotest, Inc. for the device "NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES". The FDA issued a decision of Substantially Equivalent on January 11, 1999. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Medicotest, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1999
Date Received
October 13, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle
Device Class
Class II
Regulation Number
882.1350
Review Panel
NE
Submission Type

Other clearances by Medicotest, Inc.

  • 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)
  • K973529 — NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES (November 20, 1997)
  • 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 GXZ

  • K241045 — Disposable Subdermal Needle Electrode, Corkscrew (December 11, 2024)
  • K232581 — Medical Disposable Sterile Needle Electrode (December 4, 2023)
  • K231691 — Phantom XL Insulated Dilators (June 29, 2023)
  • K200984 — Guardian Needle Electrode (May 27, 2020)
  • K192603 — Spes Medica Subdermal Needle Electrodes (November 22, 2019)
  • K190801 — PressOn Electrode Headset (July 10, 2019)
  • K161566 — DMS Disposable Subdermal Needle Electrodes (December 21, 2016)
  • K142470 — E-Shield Multi-paried Subdermal Needle Electrodes (November 5, 2014)
  • K140200 — E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES (July 18, 2014)
  • K130220 — MR CONDITIONAL PRESSON ELECTRODE (July 22, 2013)

FDA data resources