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510(k) K983597

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

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)

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  • 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)