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510(k) K022909

NIKOMED TRACE 1 ECG ELECTRODES by Nikomed U.S.A., Inc. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2003
Date Received
September 3, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrocardiograph
Device Class
Class II
Regulation Number
870.2360
Review Panel
CV
Submission Type

Other clearances by Nikomed U.S.A., Inc.

  • K000079 — NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M (February 4, 2000)
  • K950473 — DISPOSABLE ECG MONITORING ELECTRODE (December 12, 1995)
  • K950472 — DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM (November 14, 1995)
  • K950475 — DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540 (November 14, 1995)
  • K950477 — DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM (November 6, 1995)
  • K950478 — DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM (November 6, 1995)
  • K950471 — DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM (November 6, 1995)
  • K950470 — DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM (November 6, 1995)
  • K950480 — DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM (November 6, 1995)
  • K950474 — DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM (November 6, 1995)

Other clearances for product code DRX

  • K171244 — Physiotrace (August 23, 2017)
  • K140096 — HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE (July 24, 2014)
  • K123658 — BIOMODULE 3-M1 (April 24, 2013)
  • K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES (July 22, 2010)
  • K101685 — IP-SET (July 1, 2010)
  • K100129 — AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (June 11, 2010)
  • K093327 — INTCO TAB ELECTRODE (May 10, 2010)
  • K100315 — 12 LEAD GLOVE (April 23, 2010)
  • K092744 — NEONATAL ECG ELECTRODE, M203KEN (December 10, 2009)
  • K092389 — DISPOSAL ECG ELECTRODES, MODEL EASYRODE (October 13, 2009)