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510(k) K895113

COORDINATOR by Cardiotronics, Inc. — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1989
Date Received
August 15, 1989
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 Cardiotronics, Inc.

  • K932903 — EKG VEST (February 24, 1995)
  • K922064 — MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE (December 1, 1992)
  • K923297 — MODEL #340 STEALTH-TRODE+LS (September 18, 1992)
  • K922173 — MODEL # 830 ST ADULT STIMULATION PADS (STERILE) (June 11, 1992)
  • K922172 — MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) (June 11, 1992)
  • K922227 — MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE (June 11, 1992)
  • K921606 — MODEL #125 CHILD STIMULATION PADS (May 26, 1992)
  • K920086 — SHOCK-PATCH ADULT DEFIBRILLATION PADS (February 3, 1992)
  • K914725 — COORDINATOR, CABLE INPUT (November 5, 1991)
  • K912621 — MODEL #911 STEALTH MULTI PADS (October 16, 1991)

Other clearances for product code LDD

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  • 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)