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510(k) K991556

ZOLL M SERIES 12SL ANALYSIS OPTION by Zoll Medical Corp — Product Code MKJ

K991556 is an FDA 510(k) premarket notification submitted by Zoll Medical Corp for the device "ZOLL M SERIES 12SL ANALYSIS OPTION". The FDA issued a decision of ST on October 21, 1999. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. Zoll Medical Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
October 21, 1999
Date Received
May 4, 1999
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 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)
  • K042417 — ZOLL M SERIES ETC02 LOFLO OPTION (October 5, 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)

Other clearances for product code MKJ

  • K143714 — Powerheart G5 AED (May 4, 2015)
  • K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (May 2, 2015)
  • K150055 — OneStep Pediatric CPR Multi-Function Electrode (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