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510(k) K950475

DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540 by Nikomed U.S.A., Inc. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1995
Date Received
February 3, 1995
Clearance Type
Traditional
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.

  • K022909 — NIKOMED TRACE 1 ECG ELECTRODES (January 9, 2003)
  • 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)
  • K950474 — DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM (November 6, 1995)
  • K950478 — DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM (November 6, 1995)
  • K950470 — DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM (November 6, 1995)
  • K950480 — DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM (November 6, 1995)
  • K950471 — DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM (November 6, 1995)
  • K950477 — DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM (November 6, 1995)

Other clearances for product code DRX

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  • 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)