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510(k) K970639

NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K by Medicotest, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1997
Date Received
February 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
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)
  • K983597 — NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES (January 11, 1999)
  • K973529 — NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES (November 20, 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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