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510(k) K092744

NEONATAL ECG ELECTRODE, M203KEN by R & D Medical Products, Inc. — Product Code DRX

K092744 is an FDA 510(k) premarket notification submitted by R & D Medical Products, Inc. for the device "NEONATAL ECG ELECTRODE, M203KEN". The FDA issued a decision of Substantially Equivalent on December 10, 2009. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. R & D Medical Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2009
Date Received
September 8, 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 R & D Medical Products, Inc.

  • K111555 — CIRCUMAURAL ADHESIVE REPLACEMENT (July 25, 2011)
  • K001117 — COMFORT STIM (July 5, 2000)
  • K973183 — WOUND DRAINAGE HOLDER (January 23, 1998)

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)
  • K092389 — DISPOSAL ECG ELECTRODES, MODEL EASYRODE (October 13, 2009)
  • K090496 — QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH (September 1, 2009)

FDA data resources