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510(k) K133269

ZOLL X SERIES by Zoll Medical Corporation, World Wide Headquarters — Product Code MKJ

K133269 is an FDA 510(k) premarket notification submitted by Zoll Medical Corporation, World Wide Headquarters for the device "ZOLL X SERIES". The FDA issued a decision of Substantially Equivalent on May 22, 2014. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. Zoll Medical Corporation, World Wide Headquarters has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2014
Date Received
October 24, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated External Defibrillators (Non-Wearable)
Device Class
Class III
Regulation Number
870.5310
Review Panel
CV
Submission Type

This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.

Other clearances by Zoll Medical Corporation, World Wide Headquarters

  • K133239 — ZOLL E SERIES (January 16, 2015)
  • K120406 — ZOLL FULLY AUTOMATIC AED PLUS (October 26, 2012)
  • K120907 — ZOLL R SERIES (September 25, 2012)
  • K112761 — ZOLL PROPAQ MD (April 25, 2012)
  • K112432 — ZOLL X SERIES (March 21, 2012)
  • K111296 — ZOLL RESCUENETLINK (October 27, 2011)
  • K111594 — ZOLL E SERIES (August 17, 2011)
  • K110361 — ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE (March 8, 2011)
  • K110154 — ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE (February 17, 2011)
  • K110168 — ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE (February 17, 2011)

Other clearances for product code MKJ

  • K143714 — Powerheart G5 AED (May 4, 2015)
  • K150055 — OneStep Pediatric CPR Multi-Function Electrode (May 2, 2015)
  • K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (May 2, 2015)
  • K142709 — samaritan PAD 450P (March 27, 2015)
  • K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (January 23, 2015)
  • K133239 — ZOLL E SERIES (January 16, 2015)
  • K142430 — LIFEPAK 15 monitor/defibrillator (December 19, 2014)
  • K141795 — BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (December 8, 2014)
  • K142915 — ZOLL X Series (December 3, 2014)
  • K142803 — Skintact, various other tradenames (December 2, 2014)

FDA data resources