Home / 510(k) Clearances / K012274

510(k) K012274

MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER by Medtronic Physio-Control Corp. — Product Code LDD

K012274 is an FDA 510(k) premarket notification submitted by Medtronic Physio-Control Corp. for the device "MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER". The FDA issued a decision of Substantially Equivalent on February 5, 2002. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Medtronic Physio-Control Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2002
Date Received
July 19, 2001
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 Medtronic Physio-Control Corp.

  • K040775 — LIFEPAK 12 (April 23, 2004)
  • K033275 — LIFEPAK 12, 20, 500, CR PLUS (November 6, 2003)
  • K022732 — INFANT/CHILD REDUCED ENERGY ELECTRODES (December 13, 2002)
  • K011144 — LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR (December 3, 2001)
  • K012428 — MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR (September 28, 2001)
  • K010918 — LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM (August 23, 2001)
  • K002445 — LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES (January 31, 2001)

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)

FDA data resources