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510(k) K800936

R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171 by R2 Corp. — Product Code LDD

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
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type

Other clearances by R2 Corp.

  • K832516 — MAGNATRODE CARDIAC MONITORING ELECTRODE (December 16, 1983)
  • 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)
  • K800930 — R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. (May 23, 1980)
  • K800933 — R2 ELECTROSURG. RETURN ELECT. #225ETC. (May 20, 1980)
  • K800934 — R2 ESU CABLE-ADAPTER MODELS 160,161 (May 20, 1980)

Other clearances for product code LDD

  • K203231 — Switched Internal Paddles (January 11, 2021)
  • K200849 — Tempus LS - Manual (July 24, 2020)
  • K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators (June 3, 2019)
  • K150349 — Rapid Hair Removal Pads (July 14, 2015)
  • K140502 — ZOLL E SERIES ALS (November 6, 2014)
  • K103651 — CARDIOMED (October 4, 2011)
  • K103783 — EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDI (June 16, 2011)
  • K103334 — CARDIO MED (January 18, 2011)
  • K103159 — CARDIO MED MODEL A102, H104, O101, P103, AND Z100 (January 11, 2011)
  • K102468 — ZOLL PROPAQ MD (September 30, 2010)