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510(k) K020907

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2002
Date Received
March 20, 2002
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)
  • 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)
  • 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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