510(k) K042417

ZOLL M SERIES ETC02 LOFLO OPTION by Zoll Medical Corp — Product Code MKJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 5, 2004
Date Received: September 7, 2004
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 Corp

K133484 — ZOLL X SERIES (August 1, 2014)
K112660 — POCKETCPR (May 10, 2012)
K090989 — ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES (September 23, 2009)
K042007 — ZOLL E SERIES DEFIBRILLATOR (April 7, 2005)
K042302 — ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTE (October 26, 2004)
K033474 — ZOLL AED PLUS (May 21, 2004)
K032691 — ZOLL AUTOCLAVABLE INTERNAL HANDLES (November 13, 2003)
K032439 — ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) (November 5, 2003)
K032363 — ZOLL M SERIES NIBP OPTION (October 31, 2003)
K011541 — ZOLL PAD WITH CPR AID (April 11, 2002)

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)