510(k) K080232

ZOLL E SERIES 12SL, ANALYSIS OPTION by Zoll Medical Corporation, World Wide Headquarters — Product Code MKJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 23, 2008
Date Received: January 30, 2008
Clearance Type: Special
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)
K133269 — ZOLL X SERIES (May 22, 2014)
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)

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)