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510(k) K862655

SIGNA II RESTING ECG ELECTRODE by Kone Instruments, Inc. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1986
Date Received
July 14, 1986
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 Kone Instruments, Inc.

  • K873345 — 'MICROLYTE 4/5' (September 11, 1987)
  • K870777 — PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER (March 13, 1987)
  • K863466 — M700 STRESS MONITOR (December 22, 1986)
  • K860767 — MODEL E 600 ELECTROCARDIOGRAPH (April 23, 1986)
  • K853354 — MEDIC 4 (October 11, 1985)
  • K840200 — PROGRESS SELECTIVE DHEMISTRY ANALYZ (April 4, 1984)
  • K830432 — CENTRAL STATION 590 (March 24, 1983)
  • K830433 — PATIENT MONITOR 575 (March 24, 1983)
  • K822952 — 560 (November 1, 1982)
  • K820541 — MICROLYTE (May 24, 1982)

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)