Home / 510(k) Clearances / K092389

510(k) K092389

DISPOSAL ECG ELECTRODES, MODEL EASYRODE by Suzuken Co., Ltd. — Product Code DRX

K092389 is an FDA 510(k) premarket notification submitted by Suzuken Co., Ltd. for the device "DISPOSAL ECG ELECTRODES, MODEL EASYRODE". The FDA issued a decision of Substantially Equivalent on October 13, 2009. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Suzuken Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2009
Date Received
August 5, 2009
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 Suzuken Co., Ltd.

  • K172068 — Kenz Cardico1211 (June 1, 2018)
  • K101024 — KENZ CARDY302 MAX (January 6, 2011)
  • K001896 — KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHA (January 8, 2001)
  • K870443 — KENZ-CARDICO 1201 (July 1, 1987)
  • K862544 — KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH (August 6, 1986)
  • K843731 — KENZ 80Z MARK II (July 11, 1985)
  • K822968 — ELECTROCARDIOGRAPH INTERPRETER (December 15, 1982)
  • K820854 — KENZ-45M (June 1, 1982)
  • K820991 — KENZ-GELECT GEL PAD (April 26, 1982)
  • K812263 — KENZ-GELECT (November 2, 1981)

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)
  • K090496 — QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH (September 1, 2009)

FDA data resources