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510(k) K832516

MAGNATRODE CARDIAC MONITORING ELECTRODE by R2 Corp. — Product Code DRX

K832516 is an FDA 510(k) premarket notification submitted by R2 Corp. for the device "MAGNATRODE CARDIAC MONITORING ELECTRODE". The FDA issued a decision of Substantially Equivalent on December 16, 1983. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. R2 Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1983
Date Received
July 28, 1983
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 R2 Corp.

  • K800936 — R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171 (May 23, 1980)
  • K800937 — R2 PLATE TYPE CABLE-ADAPTOR #S 175,176 (May 23, 1980)
  • K800932 — ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120 (May 23, 1980)
  • K800931 — R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122 (May 23, 1980)
  • K800930 — R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. (May 23, 1980)
  • K800935 — R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) (May 23, 1980)
  • K800934 — R2 ESU CABLE-ADAPTER MODELS 160,161 (May 20, 1980)
  • K800933 — R2 ELECTROSURG. RETURN ELECT. #225ETC. (May 20, 1980)

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)

FDA data resources