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510(k) K800934

R2 ESU CABLE-ADAPTER MODELS 160,161 by R2 Corp. — Product Code IKD

K800934 is an FDA 510(k) premarket notification submitted by R2 Corp. for the device "R2 ESU CABLE-ADAPTER MODELS 160,161". The FDA issued a decision of Substantially Equivalent on May 20, 1980. The device falls under product code IKD (Cable, Electrode), a Class II device regulated under 21 CFR 890.1175. R2 Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1980
Date Received
April 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Electrode
Device Class
Class II
Regulation Number
890.1175
Review Panel
PM
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)
  • K800930 — R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. (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)
  • K800933 — R2 ELECTROSURG. RETURN ELECT. #225ETC. (May 20, 1980)

Other clearances for product code IKD

  • K070926 — ELECTRODE/EXTENSION CABLES, MODELS ATAR (June 7, 2007)
  • K992372 — THE LEADAWAY (October 13, 1999)
  • K935260 — PHYSIOMETRIX CABLE ADAPTER MODIFICATION (December 23, 1993)
  • K873361 — LIFE-SPAN CABLE (November 9, 1987)
  • K834583 — CLEAR LEADS-RADIOTRANSPARENT WIRES (January 30, 1984)

FDA data resources