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510(k) K140502

ZOLL E SERIES ALS by ZOLL Medical Corporation — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2014
Date Received
February 27, 2014
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

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  • K172653 — Power Infuser (July 18, 2018)
  • K162832 — 731 Series Ventilators (August 2, 2017)
  • K170533 — Model 330 Multifunction Aspirator (April 18, 2017)
  • K142915 — ZOLL X Series (December 3, 2014)
  • K141774 — ZOLL X SERIES (November 19, 2014)
  • K132488 — ZOLL CODE WRITER (April 3, 2014)
  • K131919 — ZOLL EPCR IOS (December 17, 2013)

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)
  • 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)
  • K100654 — ZOLL PROPAQ MD (July 29, 2010)