Product Code: MKJ FDA class 3 21 CFR 870.5310

Automated External Defibrillators (Non-Wearable)

Cardiovascular

The Non-Wearable Automated External Defibrillator (AED) is a portable prescription-use-only device that automatically analyzes a patient's cardiac rhythm and, when a shockable rhythm such as ventricular fibrillation or pulseless ventricular tachycardia is detected, delivers a defibrillation shock to restore normal cardiac rhythm, intended for use in clinical or emergency settings rather than worn on the patient's body. Classified as a Class 3 device under 21 CFR 870.5310 within the Cardiovascular specialty, it requires Premarket Approval (PMA). It carries no implant flag but is a critical life-saving device used in cardiac emergencies.

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510(k)s

228

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MKJ
Device Class: FDA class 3
Regulation Number: 870.5310
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 2

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 228 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K143714	Powerheart G5 AED	May 04, 2015	Substantially Equivalent	Cardiac Science Corporation
K150198	CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel	May 02, 2015	Substantially Equivalent	Bio-Detek, Inc.
K150055	OneStep Pediatric CPR Multi-Function Electrode	May 02, 2015	Substantially Equivalent	Bio-Detek, Inc.
K142709	samaritan PAD 450P	Mar 27, 2015	Substantially Equivalent	Heartsine Technologies, Inc.
K133659	HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING	Jan 23, 2015	Substantially Equivalent	Philips Medical Systems
K133239	ZOLL E SERIES	Jan 16, 2015	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K142430	LIFEPAK 15 monitor/defibrillator	Dec 19, 2014	Substantially Equivalent	Physio-Control, Inc.
K141795	BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500	Dec 08, 2014	Substantially Equivalent	R & D Batteries, Inc.
K142915	ZOLL X Series	Dec 03, 2014	Substantially Equivalent	ZOLL Medical Corporation
K142803	Skintact, various other tradenames	Dec 02, 2014	Substantially Equivalent	Leonhard Lang GmbH
K141231	ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY	Nov 25, 2014	Substantially Equivalent	Zeller Power Products (Battery Beast, LLC)
K141774	ZOLL X SERIES	Nov 19, 2014	Substantially Equivalent	ZOLL Medical Corporation
K133441	ONESTEP CPR II MULTI-FUNCTION ELECTRODE	Oct 10, 2014	Substantially Equivalent	Bio-Detek, Inc.
K133484	ZOLL X SERIES	Aug 01, 2014	Substantially Equivalent	Zoll Medical Corp
K133269	ZOLL X SERIES	May 22, 2014	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K131525	SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES	Apr 24, 2014	Substantially Equivalent	Defibtech, LLC
K122758	POWERHEART G5 AED	Feb 12, 2014	Substantially Equivalent	Cardiac Science Corporation
K131550	HEART SYNC	Dec 06, 2013	Substantially Equivalent	Heart Sync, Inc.
K130684	PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR	Oct 18, 2013	Substantially Equivalent	Philips Medical Systems
K131494	HEART SYNC	Sep 16, 2013	Substantially Equivalent	Heart Sync, Inc.
K130454	LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR	Aug 21, 2013	Substantially Equivalent	Physio-Control, Inc.
K123881	HEARTSINE SAMARITAN PAD 350P	Jul 11, 2013	Substantially Equivalent	Heartsine Technologies, Inc.
K130153	HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST	Mar 12, 2013	Substantially Equivalent	Philips Medical Systems
K113787	DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES	Jan 04, 2013	Substantially Equivalent	Defibtech, LLC
K122839	ZOLL SUREPOWER SINGLE BAY CHARGER	Dec 13, 2012	Substantially Equivalent	ZOLL Medical Corporation
K121853	DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES	Dec 13, 2012	Substantially Equivalent	Defibtech, LLC
K120350	EXTENDED LIFE BATTERY	Nov 01, 2012	Substantially Equivalent	Aed Battery Exchange, LLC
K120406	ZOLL FULLY AUTOMATIC AED PLUS	Oct 26, 2012	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K122600	LIFEPAK 1000 DEFIBRILLATOR	Oct 11, 2012	Substantially Equivalent	Physio-Control, Inc.
K120907	ZOLL R SERIES	Sep 25, 2012	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K120536	HEART SYNC PEDIATRIC PHYSIO AED PAD	Aug 06, 2012	Substantially Equivalent	Heart Sync, Inc.
K112761	ZOLL PROPAQ MD	Apr 25, 2012	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K112432	ZOLL X SERIES	Mar 21, 2012	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K110825	PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES	Feb 16, 2012	Substantially Equivalent	Philips Medical Systems
K111693	PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR	Oct 28, 2011	Substantially Equivalent	Philips Medical Systems
K111594	ZOLL E SERIES	Aug 17, 2011	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K102496	POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS	Jun 09, 2011	Substantially Equivalent	Cardiac Science Corporation
K110978	ONESTEP PEDIATRIC MFE'S	May 13, 2011	Substantially Equivalent	ZOLL Medical Corporation
K110742	ONESTEP ADULT MULTI-FUNCTION ELECTRODE	Apr 13, 2011	Substantially Equivalent	ZOLL Medical Corporation
K110526	ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE	Mar 25, 2011	Substantially Equivalent	ZOLL Medical Corporation
K103567	LIFEPAK 15 MONITOR/DEFIBRILLATOR	Mar 22, 2011	Substantially Equivalent	Physio-Control, Inc.
K110361	ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE	Mar 08, 2011	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K110168	ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE	Feb 17, 2011	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K110154	ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE	Feb 17, 2011	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K103186	SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES	Feb 08, 2011	Substantially Equivalent	Leonhard Lang GmbH
K102972	LIFEPAK 12	Dec 22, 2010	Substantially Equivalent	Physio-Control, Inc.
K100565	DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325	Nov 16, 2010	Substantially Equivalent	Bio-Detek, Inc.
K091561	ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE	Sep 23, 2010	Substantially Equivalent	ZOLL Medical Corporation
K092391	MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED	Apr 01, 2010	Substantially Equivalent	Concord Medical Products
K091265	ZOLL E SERIES WITH CPRREADYCHARGE	Dec 23, 2009	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K092598	ZOLL E SERIES WITH SPCO/SPMET OPTION	Dec 03, 2009	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K090989	ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES	Sep 23, 2009	Substantially Equivalent	Zoll Medical Corp
K091943	POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A	Sep 10, 2009	Substantially Equivalent	Cardiac Science Corporation
K091548	AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A	Aug 07, 2009	Substantially Equivalent	Amco International Manufacturing & Design, Inc.
K081259	DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES	Jun 15, 2009	Substantially Equivalent	Defibtech, LLC
K082937	LIFEPAK 15 MONITOR/DEFIBRILLATOR	Mar 11, 2009	Substantially Equivalent	Physio-Control, Inc.
K081081	ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING	Mar 09, 2009	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K082090	9131 DEFIBRILLATION ELECTRODES	Dec 12, 2008	Substantially Equivalent	Cardiac Science Corporation
K081828	ZOLL R SERIES BLS DEFIBRILLATOR	Dec 09, 2008	Substantially Equivalent	ZOLL Medical Corporation
K080903	ZOLL E SERIES WITH INTIBATION ASSIST OPTION	Dec 04, 2008	Substantially Equivalent	ZOLL Medical Corporation
K082861	AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561	Nov 25, 2008	Substantially Equivalent	Amco International Manufacturing & Design, Inc.
K081371	SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL	Sep 24, 2008	Substantially Equivalent	Leonhard Lang GmbH
K073089	LIFEPAK 20E	Jul 29, 2008	Substantially Equivalent	Physio-Control, Inc.
K072923	ZOLL E SERIES DEFIBRILLATOR	Apr 24, 2008	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K080232	ZOLL E SERIES 12SL, ANALYSIS OPTION	Apr 23, 2008	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K073716	LIFE+CEL OR LIFECEL BATTERY	Apr 11, 2008	Substantially Equivalent	Amco International Manufacturing & Design, Inc.
K080421	HEART SYNC, MODELS C-100 AND T-100	Feb 29, 2008	Substantially Equivalent	Heart Sync, LLC
K072812	PHILIPS HEARTSTART SMARTPADS III	Feb 26, 2008	Substantially Equivalent	Philips Medical Systems
K072596	LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500	Jan 24, 2008	Substantially Equivalent	Amco International Manufacturing & Design, Inc.
K062970	I-PAD	Jan 22, 2008	Substantially Equivalent	Cu Medical Systems, Inc.
K072430	ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE	Nov 06, 2007	Substantially Equivalent	ZOLL Medical Corporation
K072233	SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS	Oct 05, 2007	Substantially Equivalent	Leonhard Lang GmbH
K071025	ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO	Jun 22, 2007	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K070455	ZOLL E SERIES WITH SEE-THRU CPR	Apr 26, 2007	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K062537	ZOLL M SERIES WITH REAL CPR HELP	Feb 28, 2007	Substantially Equivalent	ZOLL Medical Corporation
K063510	LIFEPAK 12 DEFIBRILLATOR/MONITOR	Jan 26, 2007	Substantially Equivalent	Medtronic Emergency Response Systems, Inc.
K063375	HEARTSTART MRX, MODELS M3535A OR M3536A	Jan 11, 2007	Substantially Equivalent	Philips Medical Systems
K063119	LIFEPAK 20 DEFIBRILLATOR/ MONITOR	Dec 22, 2006	Substantially Equivalent	Medtronic Emergency Response Systems, Inc.
K062177	ZOLL E SERIES WITH REAL CPR HELP	Dec 13, 2006	Substantially Equivalent	ZOLL Medical Corporation
K052465	REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351	Dec 12, 2006	Substantially Equivalent	Heartsine Technologies, Inc.
K062233	HEARTSTART MRX MONITOR/DEFIBRILLATOR	Nov 22, 2006	Substantially Equivalent	Philips Medical Systems North America, Inc.
K060559	ZOLL R SERIES DEFIBRILLATOR	Aug 17, 2006	Substantially Equivalent	ZOLL Medical Corporation
K061707	HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS	Aug 11, 2006	Substantially Equivalent	Philips Medical Systems
K060934	MODIFICATION TO POWERHEART ECD	May 15, 2006	Substantially Equivalent	Cardiac Science Corporation
K052057	LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR	Feb 17, 2006	Substantially Equivalent	Medtronic Emergency Response Systems, Inc.
K052316	POWERHEART ECD	Jan 03, 2006	Substantially Equivalent	Cardiac Science, Inc.
K042404	LIFEPAK, MODEL 1000	Dec 22, 2005	Substantially Equivalent	Medtronic Emergency Response Systems, Inc.
K052161	POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)	Oct 21, 2005	Substantially Equivalent	Cardiac Science, Inc.
K051632	PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A	Oct 05, 2005	Substantially Equivalent	Philips Medical Systems
K051134	HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A	Sep 08, 2005	Substantially Equivalent	Philips Medical Systems
K051475	ZOLL M SERIES 12SL ANALYSIS OPTION	Jun 24, 2005	Substantially Equivalent	ZOLL Medical Corporation
K051076	ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES	May 13, 2005	Substantially Equivalent	ZOLL Medical Corporation
K042007	ZOLL E SERIES DEFIBRILLATOR	Apr 07, 2005	Substantially Equivalent	Zoll Medical Corp
K050004	PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304	Feb 25, 2005	Substantially Equivalent	Philips Medical Systems
K041892	ZOLL AED PRO EXTERNAL DEFIBRILLATOR	Feb 04, 2005	Substantially Equivalent	ZOLL Medical Corporation
K042417	ZOLL M SERIES ETC02 LOFLO OPTION	Oct 05, 2004	Substantially Equivalent	Zoll Medical Corp
K040479	PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20	Sep 14, 2004	Substantially Equivalent	Welch Allyn, Inc.
K041883	SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21	Sep 07, 2004	Substantially Equivalent	Leonhard Lang GmbH
K042088	SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301	Sep 02, 2004	Substantially Equivalent	Heartsine Technologies, Inc.
K040637	POWERHEART AED G3 PRO	Aug 06, 2004	Substantially Equivalent	Cardiac Science, Inc.
K041459	LIFEPAK 12 DEFIBRILLATOR/MONITOR	Jul 01, 2004	Substantially Equivalent	Medtronic Emergency Response Systems, Inc.
K040438	POWERHEART AED G3A	Jul 01, 2004	Substantially Equivalent	Cardiac Science, Inc.
K033896	DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P	Jun 16, 2004	Substantially Equivalent	Defibtech, LLC
K041067	HEARTSINE SAMARITAN PAD	May 25, 2004	Substantially Equivalent	Heartsine Technologies, Inc.
K033642	SMARTLANK WIRELESS, MODEL 001970	May 25, 2004	Substantially Equivalent	Mrl, A Welch Allyn Company
K033474	ZOLL AED PLUS	May 21, 2004	Substantially Equivalent	Zoll Medical Corp
K040404	HEARTSTART MRX, MODEL M3535A	May 04, 2004	Substantially Equivalent	Philips Medical Systems, Inc.
K040775	LIFEPAK 12	Apr 23, 2004	Substantially Equivalent	Medtronic Physio-Control Corp.
K040256	PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005	Apr 09, 2004	Substantially Equivalent	Bio-Detek, Inc.
K040056	BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90	Apr 09, 2004	Substantially Equivalent	Bio-Detek, Inc.
K033771	BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR	Feb 27, 2004	Substantially Equivalent	Bio-Detek, Inc.
K032421	AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE	Feb 27, 2004	Substantially Equivalent	Ambu, Inc.
K032051	BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P	Jan 09, 2004	Substantially Equivalent	Access Battery, Inc.
K033144	DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES	Nov 13, 2003	Substantially Equivalent	Defibtech, LLC
K033275	LIFEPAK 12, 20, 500, CR PLUS	Nov 06, 2003	Substantially Equivalent	Medtronic Physio-Control Corp.
K032439	ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)	Nov 05, 2003	Substantially Equivalent	Zoll Medical Corp
K031187	HEARTSTART MRX, MODEL M3535A	Aug 27, 2003	Substantially Equivalent	Philips Medical Systems
K030898	MOBILE BATTERY SERVICE STATION (MBSS)	Aug 27, 2003	Substantially Equivalent	Ad Elektronik GmbH
K031987	POWERHEART AED G3, MODEL 9300	Jul 30, 2003	Substantially Equivalent	Cardiac Science
K023854	SAMARITAN AED, MODEL SAM-01	Feb 14, 2003	Substantially Equivalent	Heartsine Technologies, Inc.
K022929	PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210	Jan 27, 2003	Substantially Equivalent	Cardiac Science, Inc.
K022732	INFANT/CHILD REDUCED ENERGY ELECTRODES	Dec 13, 2002	Substantially Equivalent	Medtronic Physio-Control Corp.
K020715	PHILIPS M5066A AND M5068A	Nov 08, 2002	Substantially Equivalent - Subject to Tracking Reg.	Philips Medical Systems
K022210	MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650	Oct 04, 2002	Substantially Equivalent	Cardiac Science, Inc.
K020984	ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS	Aug 14, 2002	Substantially Equivalent - Subject to Tracking Reg.	Access Cardiosystems, Inc.
K021453	HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A	Jul 03, 2002	Substantially Equivalent	Philips Medical Systems
K021168	JUMP START, MODEL 970300	Jun 26, 2002	Substantially Equivalent - Subject to Tracking Reg.	Medical Research Laboratories, Inc.
K013896	SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA	Jun 19, 2002	Substantially Equivalent - Subject to Tracking Reg.	Defibtech, LLC
K020743	PADPRO, MODEL 2502	May 28, 2002	Substantially Equivalent	Padpro, LLC
K020203	PADPRO MODEL #2516	May 08, 2002	Substantially Equivalent	Padpro, LLC
K011541	ZOLL PAD WITH CPR AID	Apr 11, 2002	Substantially Equivalent - Subject to Tracking Reg.	Zoll Medical Corp
K011388	ZOLL PAD	Mar 25, 2002	Substantially Equivalent	Zoll Medical Corp
K020288	PADPRO, MODEL 2603	Feb 27, 2002	Substantially Equivalent	Padpro, LLC
K011901	FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200	Feb 01, 2002	Substantially Equivalent	Survivalink Corp.
K012766	PORTABLE INTENSIVE CARE UNIT	Jan 23, 2002	Substantially Equivalent - Subject to Tracking Reg.	Medical Research Laboratories, Inc.
K014209	PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS	Jan 18, 2002	Substantially Equivalent	Padpro, LLC
K014157	HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A	Jan 17, 2002	Substantially Equivalent - Subject to Tracking Reg.	Philips Medical Systems
K013425	HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A	Jan 14, 2002	Substantially Equivalent	Philips Medical Systems
K011144	LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR	Dec 03, 2001	Substantially Equivalent	Medtronic Physio-Control Corp.
K012197	POWERHEART CARDIAC RHYTHM MODULE	Nov 16, 2001	Substantially Equivalent	Cardiac Science, Inc.
K012428	MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR	Sep 28, 2001	Substantially Equivalent	Medtronic Physio-Control Corp.
K012030	PORTABLE INTENSIVE CARE UNIT	Sep 24, 2001	Substantially Equivalent	Medical Research Laboratories, Inc.
K003548	PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS	Sep 04, 2001	Substantially Equivalent	Padpro, LLC
K010918	LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM	Aug 23, 2001	Substantially Equivalent - Subject to Tracking Reg.	Medtronic Physio-Control Corp.
K010207	PORTABLE INSTENSIVE CARE UNIT	Jun 14, 2001	Substantially Equivalent - Subject to Tracking Reg.	Medical Research Laboratories, Inc.
K010634	HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B	Jun 11, 2001	Substantially Equivalent	Agilent Technologies, Inc.
K003819	HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A	May 02, 2001	Substantially Equivalent	Agilent Technologies, Inc.
K010257	ZOLL M SERIES	Feb 28, 2001	Substantially Equivalent	Zoll Medical Corp
K010214	FIRSTSAVE BIPHASIC MODEL #9200 AND 9210	Feb 22, 2001	Substantially Equivalent	Survivalink Corp.
K002079	MULTI-FUNCTION DEFIBRILLATION ELECTRODE	Feb 22, 2001	Substantially Equivalent	Medicotest A/S
K002280	PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602	Feb 05, 2001	Substantially Equivalent	Medical Devices, Inc.
K002445	LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES	Jan 31, 2001	Substantially Equivalent - Subject to Tracking Reg.	Medtronic Physio-Control Corp.
K003565	HEARTSTREAM FR2 AED, MODEL M3860A,M3861A	Dec 20, 2000	Substantially Equivalent	Agilent Technologies, Inc.
K003228	K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A	Dec 14, 2000	Substantially Equivalent	Katecho, Inc.
K002232	AEDEFIBRILLATOR	Dec 06, 2000	Substantially Equivalent	Medical Research Laboratories, Inc.
K002806	K-DEFIB/PACE, MODEL KDP-60A	Nov 21, 2000	Substantially Equivalent	Katecho, Inc.
K000638	RESPONDER 3000	Oct 30, 2000	Substantially Equivalent	Ge Medical Systems Information Technologies GmbH
K001725	HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A	Sep 08, 2000	Substantially Equivalent	Agilent Technologies, Inc.
K992543	HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE	May 18, 2000	Substantially Equivalent	Hewlett-Packard Co.
K993036	ZOLL M SERIES ETCO2 OPTION	Feb 28, 2000	Substantially Equivalent - Subject to Tracking Reg.	Zoll Medical Corp
K993745	K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80	Feb 03, 2000	Substantially Equivalent	Katecho, Inc.
K993533	POWERHEART AECD	Jan 24, 2000	Substantially Equivalent - Subject to Tracking Reg.	Cardiac Science, Inc.
K993072	SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)	Dec 10, 1999	Substantially Equivalent	Survivalink Corp.
K992977	HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A	Dec 01, 1999	Substantially Equivalent	Hewlett-Packard Co.
K991556	ZOLL M SERIES 12SL ANALYSIS OPTION	Oct 21, 1999	Substantially Equivalent - Subject to Tracking Reg.	Zoll Medical Corp
K991910	LIFEPAK 12 BIPHASIC	Sep 03, 1999	Substantially Equivalent - Subject to Tracking Reg.	Physio-Control Corp.
K990762	ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)	Sep 03, 1999	Substantially Equivalent - Subject to Tracking Reg.	Zoll Medical Corp
K991007	K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60	Aug 23, 1999	Substantially Equivalent	Katecho, Inc.
K991871	HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A	Aug 05, 1999	Substantially Equivalent	Hewlett-Packard Co.
K983393	LIFEPAK 500 BIPHASIC	May 05, 1999	Substantially Equivalent - Subject to Tracking Reg.	Physio-Control Corp.
K984582	ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX	Mar 16, 1999	Substantially Equivalent	Bio-Detek, Inc.
K982992	ZOLL M SERIES SPO2 OPTION	Mar 11, 1999	Substantially Equivalent - Subject to Tracking Reg.	Zoll Medical Corp
K990106	ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES	Feb 26, 1999	Substantially Equivalent	Bio-Detek, Inc.
K982264	FIRSTSAVE BIPHASIC MODELS 9200 AND 9210	Jan 25, 1999	Substantially Equivalent - Subject to Tracking Reg.	Survivalink Corp.
K984286	HEARTSTREAM ELECTRODE ADAPTER	Dec 17, 1998	Substantially Equivalent	Hewlett-Packard Co.
K981737	K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60	Dec 09, 1998	Substantially Equivalent	Katecho, Inc.
K981802	ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003	Nov 25, 1998	Substantially Equivalent	Bio-Detek, Inc.
K983307	MODIFICATION TO PORTABLE INTENSIVE CARE UNIT	Nov 20, 1998	Substantially Equivalent	Medical Research Laboratories, Inc.
K983287	MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE	Nov 05, 1998	Substantially Equivalent	Graphic Controls Corp.
K982025	HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR	Sep 04, 1998	Substantially Equivalent - Subject to Tracking Reg.	Hewlett-Packard Co.
K982710	AECD ARRHYTHMIA DETECTION SOFTWARE	Aug 10, 1998	Substantially Equivalent - Subject to Tracking Reg.	Cardiac Science, Inc.
K965117	LIFE SUPPORT FOR TRAUMA AND TRANSPORT	Jun 26, 1998	Substantially Equivalent - Subject to Tracking Reg.	Northrop Grumman Corp.
K980857	MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE	May 12, 1998	Substantially Equivalent	Graphic Controls Corp.
K972241	ZOLL REVIVER	Mar 16, 1998	Substantially Equivalent	Zoll Medical Corp
K973486	LIFE PAK 12	Jan 09, 1998	Substantially Equivalent	Physio-Control Corp.
K962359	LIFEPAK 300	Nov 06, 1997	Substantially Equivalent	Physio-Control Corp.
K970741	POWERHEART AECD	Oct 16, 1997	Substantially Equivalent	Cardiac Science, Inc.
K972418	HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)	Sep 25, 1997	Substantially Equivalent	Heartstream, Inc.
K972970	MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE	Aug 27, 1997	Substantially Equivalent	Graphic Controls Corp.
K955890	FIRST MEDIC PULSE OXIMETRY MODULE	Jul 28, 1997	Substantially Equivalent	Colorado Medtech, Inc.
K971149	SVL-9130 DEFIBRILLATION ELECTRODE	Jun 23, 1997	Substantially Equivalent	Survivalink Corp.
K971148	700-SP SERIES DISPOSABLE STIMULATION ELECTRODES	May 15, 1997	Substantially Equivalent	Cardiotronics Systems, Inc.
K970719	700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES	Apr 16, 1997	Substantially Equivalent	Cardiotronics Systems, Inc.
K970391	QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES	Mar 06, 1997	Substantially Equivalent	Contour Medical Technology, Inc.
K964991	700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES	Jan 15, 1997	Substantially Equivalent	Cardiotronics Systems, Inc.
K955854	LIFEPAK 500	Nov 04, 1996	Substantially Equivalent	Physio-Control Corp.
K955923	MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL	Oct 24, 1996	Substantially Equivalent	Graphic Controls Corp.
K955882	MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS	Oct 24, 1996	Substantially Equivalent	Graphic Controls Corp.
K955628	FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS	Sep 10, 1996	Substantially Equivalent	Heartstream, Inc.
K955828	MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORS	Jul 25, 1996	Substantially Equivalent	Graphic Controls Corp.
K960329	DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD	Jul 02, 1996	Substantially Equivalent	Contour Medical Technology, Inc.
K954957	CODEMASTER XL + XL W/SHOCK ADVISORY OPTION	May 07, 1996	Substantially Equivalent	Hewlett-Packard Co.
K953204	PEDIATRIC QUIK-COMBO	Jan 11, 1996	Substantially Equivalent	Physio-Control Corp.
K954609	HEARTSTART 911	Jan 04, 1996	Substantially Equivalent	Laerdal Medical Corp.
K954504	K-DEFIB/PACE PEDIATRIC ELECTRODE	Nov 17, 1995	Substantially Equivalent	Katecho, Inc.
K952101	MARQUETTE DEFIB ELECTRODES	Sep 07, 1995	Substantially Equivalent	Marquette Electronics, Inc.
K941262	MARQUETTE DEFIB ELECTRODE	Apr 20, 1995	Substantially Equivalent	Marquette Electronics, Inc.
K942344	ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR	Mar 13, 1995	Substantially Equivalent	Zoll Medical Corp
K942850	ZOLL POWERBASE(TM)	Feb 10, 1995	Substantially Equivalent	Zoll Medical Corp
K940445	VIVALINK AED DEFIBRILLATOR	Feb 09, 1995	Substantially Equivalent	Survivalink Corp.
K934692	K-DEFIB/PACE PEDIATRIC ELECTRODE	Jan 24, 1995	Substantially Equivalent	Katecho, Inc.
K943698	STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES	Dec 28, 1994	Substantially Equivalent	Zoll Medical Corp
K935922	360 SLX ADVISORY DEFIBRILLATOR	Dec 22, 1994	Substantially Equivalent	Medical Research Laboratories, Inc.
K941970	FAST-PATCH	Dec 07, 1994	Substantially Equivalent	Physio-Control Corp.
K925936	LIFEPAK 300 AUTOMATIC ADVISORY DEFRILLATOR	Jun 08, 1994	Substantially Equivalent	Physio-Control Corp.
K932028	PD-1400 PACER/DEFIBRILLATOR	Oct 08, 1993	Substantially Equivalent	Zoll Medical Corp
K932931	D1400 DEFIBRILLATOR W/ DEFIBRILLATION ADVISORY OPT	Oct 07, 1993	Substantially Equivalent	Zoll Medical Corp
K926172	SERIES 1500 DEFIBRILLATOR, MODIFICATION	Feb 25, 1993	Substantially Equivalent	Marquette Electronics, Inc.
K896919	HEARTSTART 3000	May 03, 1990	Substantially Equivalent	Laerdal Medical Corp.
K892005	SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9	Jun 20, 1989	Substantially Equivalent	Physio-Control Corp.
K892065	LIFEPAK 250 DEFIBRILLATOR/MONITOR	Jun 05, 1989	Substantially Equivalent	Physio-Control Corp.
K882067	MARQUETTE 1200 DEFIBRILLATOR	Nov 17, 1988	Substantially Equivalent	Marquette Electronics, Inc.
K883584	FIRST MEDIC MODE 610	Oct 06, 1988	Substantially Equivalent	First Medical Devices Corp.
K883344	HEARTSTART 1000S	Sep 12, 1988	Substantially Equivalent	Laerdal Mfg. Corp.
K883341	HEARTSTART 1000	Sep 12, 1988	Substantially Equivalent	Laerdal Mfg. Corp.
K870622	HEART*AID 1000	Apr 10, 1987	Substantially Equivalent	Cardiac Resucitator Corp.
K860676	HEARTSTART 2000	Apr 30, 1986	Substantially Equivalent	First Medical Devices Corp.
K853564	LIFEPAK 200	Oct 11, 1985	Substantially Equivalent	Physio-Control Corp.