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510(k) K853354

MEDIC 4 by Kone Instruments, Inc. — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1985
Date Received
August 12, 1985
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 Kone Instruments, Inc.

  • K873345 — 'MICROLYTE 4/5' (September 11, 1987)
  • K870777 — PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER (March 13, 1987)
  • K863466 — M700 STRESS MONITOR (December 22, 1986)
  • K862655 — SIGNA II RESTING ECG ELECTRODE (August 6, 1986)
  • K860767 — MODEL E 600 ELECTROCARDIOGRAPH (April 23, 1986)
  • K840200 — PROGRESS SELECTIVE DHEMISTRY ANALYZ (April 4, 1984)
  • K830432 — CENTRAL STATION 590 (March 24, 1983)
  • K830433 — PATIENT MONITOR 575 (March 24, 1983)
  • K822952 — 560 (November 1, 1982)
  • K820541 — MICROLYTE (May 24, 1982)

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)