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510(k) K800930

R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. by R2 Corp. — Product Code DRX

K800930 is an FDA 510(k) premarket notification submitted by R2 Corp. for the device "R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.". The FDA issued a decision of Substantially Equivalent on May 23, 1980. 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
May 23, 1980
Date Received
April 21, 1980
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.

  • K832516 — MAGNATRODE CARDIAC MONITORING ELECTRODE (December 16, 1983)
  • K800936 — R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171 (May 23, 1980)
  • K800931 — R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122 (May 23, 1980)
  • K800935 — R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) (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)
  • 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