Product Code: LDD FDA class 2 21 CFR 870.5300

Dc-Defibrillator, Low-Energy, (Including Paddles)

Cardiovascular

A low-energy DC defibrillator with paddles is a cardiovascular device used to deliver controlled electrical shocks to the heart to terminate life-threatening arrhythmias such as ventricular fibrillation or pulseless ventricular tachycardia. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is LDD, regulated under 21 CFR 870.5300, in the Cardiovascular specialty. This device is designated as life sustaining or life supporting, reflecting its critical role in emergency cardiac care.

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510(k)s

166

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LDD
Device Class: FDA class 2
Regulation Number: 870.5300
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 166 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K203231	Switched Internal Paddles	Jan 11, 2021	Substantially Equivalent	Philips North America, LLC
K200849	Tempus LS - Manual	Jul 24, 2020	Substantially Equivalent	Remote Diagnostic Technologies, Ltd. A Philips Company
K182503	Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors	Jun 03, 2019	Substantially Equivalent	Physio-Control, Inc.
K150349	Rapid Hair Removal Pads	Jul 14, 2015	Substantially Equivalent	Full Power Aed
K140502	ZOLL E SERIES ALS	Nov 06, 2014	Substantially Equivalent	ZOLL Medical Corporation
K103651	CARDIOMED	Oct 04, 2011	Substantially Equivalent	Cardio Medical Products, Inc.
K103783	EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC	Jun 16, 2011	Substantially Equivalent	Fiab Spa
K103334	CARDIO MED	Jan 18, 2011	Substantially Equivalent	Cardio Medical Products, Inc.
K103159	CARDIO MED MODEL A102, H104, O101, P103, AND Z100	Jan 11, 2011	Substantially Equivalent	Cardio Medical Products, Inc.
K102468	ZOLL PROPAQ MD	Sep 30, 2010	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K100654	ZOLL PROPAQ MD	Jul 29, 2010	Substantially Equivalent	Zoll Medical Corporation, World Wide Headquarters
K081442	HEART SYNC PEDIATRIC, MODEL PED-100	Sep 24, 2008	Substantially Equivalent	Heart Sync, LLC
K081574	ZOLL R SERIES	Sep 18, 2008	Substantially Equivalent	ZOLL Medical Corporation
K042302	ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE	Oct 26, 2004	Substantially Equivalent	Zoll Medical Corp
K032691	ZOLL AUTOCLAVABLE INTERNAL HANDLES	Nov 13, 2003	Substantially Equivalent	Zoll Medical Corp
K030417	DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES	May 09, 2003	Substantially Equivalent	Philips Medical Systems
K011461	ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR	May 28, 2002	Substantially Equivalent	Access Cardiosystems, Inc.
K012274	MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER	Feb 05, 2002	Substantially Equivalent	Medtronic Physio-Control Corp.
K993205	BOOKER BOX, MODEL PAD 5010	Jul 20, 2000	Substantially Equivalent	Tz Medical, Inc.
K982896	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9	Oct 21, 1998	Substantially Equivalent - Subject to Tracking Reg.	Alexander Mfg. Co.
K971436	NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES	Oct 21, 1997	Substantially Equivalent - Subject to Tracking Reg.	Nihon Kohden America, Inc.
K971355	NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES	Jul 15, 1997	Substantially Equivalent - Subject to Tracking Reg.	Nihon Kohden America, Inc.
K971194	NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES	Jul 09, 1997	Substantially Equivalent - Subject to Tracking Reg.	Nihon Kohden America, Inc.
K970481	V2	Jul 01, 1997	Substantially Equivalent - Subject to Tracking Reg.	Survivalink Corp.
K963781	ZOLL AUTOCLAVABLE INTERNAL HANDLES	May 20, 1997	Substantially Equivalent - Subject to Tracking Reg.	Zoll Medical Corp
K964469	700-F SERIES STIMULATION ELECTRODES	Dec 11, 1996	Substantially Equivalent	Cardiotronics Systems, Inc.
K962551	CARDIOSERV S	Nov 19, 1996	Substantially Equivalent - Subject to Tracking Reg.	Marquette Electronics, Inc.
K951110	CARDIO SERV	Sep 15, 1995	Substantially Equivalent	Hellige GmbH
K952085	DPD DEFIBRILLATOR	Jun 05, 1995	Substantially Equivalent - Subject to Tracking Reg.	Medical Research Laboratories, Inc.
K940842	UNIPOWER RECHARGEABLE BATTERY PACK	Sep 07, 1994	Substantially Equivalent - Subject to Tracking Reg.	Unipower Corp.
K941995	NCE REPLACEMENT BATTERIES	Jul 26, 1994	Substantially Equivalent - Subject to Tracking Reg.	National Custom Ent., Inc.
K935083	PEDIATRIC DEFIB K-PADS	Jul 25, 1994	Substantially Equivalent - Subject to Tracking Reg.	Katecho, Inc.
K935111	UNIPOWERR RECHARGEABLE BATTERY PACK	Mar 28, 1994	Substantially Equivalent	Unipower Corp.
K922315	VITAL-COMBO(R)	Mar 16, 1994	Substantially Equivalent	Physio-Control Corp.
K934508	BATTERY PACK# S1024NC	Feb 17, 1994	Substantially Equivalent	Portable Power Systems, Inc.
K934015	RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB	Feb 17, 1994	Substantially Equivalent	Portable Power Systems, Inc.
K931266	BATTERY PACK #1012NC	Feb 03, 1994	Substantially Equivalent	Portable Power Systems, Inc.
K935674	LIFEPAK 9 DEFIBRILLATOR/MONITOR	Dec 16, 1993	Substantially Equivalent	Physio-Control Corp.
K931787	ZOLL PD 5300	Oct 15, 1993	Substantially Equivalent	Zoll Medical Corp
K931805	ZOLL PD 5200C ADULT SOLID GEL MULTI-FUNCTION ELECT	Oct 08, 1993	Substantially Equivalent	Zoll Medical Corp
K931804	ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTRO	Oct 08, 1993	Substantially Equivalent	Zoll Medical Corp
K931803	5200 ADULT SOLID GEL MULTI-FUNCTION ELECTRODES	Oct 08, 1993	Substantially Equivalent	Zoll Medical Corp
K921666	CARDIAC THERAPHY SYSTEM SCP 900	Sep 23, 1993	Substantially Equivalent	Ppg Hellige B.V.
K930548	DPD DEFIBRILLATOR	Jun 25, 1993	Substantially Equivalent	Medical Research Laboratories, Inc.
K931053	LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER	May 18, 1993	Substantially Equivalent	Physio-Control Corp.
K921765	PRIMEDIC DEFIBRILLATORS-N/B	Mar 03, 1993	Substantially Equivalent	Metronic Electronic GmbH
K921487	MARQUETTE SERIES 360 DEFIBRILLATOR	Dec 29, 1992	Substantially Equivalent	Marquette Electronics, Inc.
K923864	BATTERY PACK	Oct 05, 1992	Substantially Equivalent	Portable Power Systems, Inc.
K923297	MODEL #340 STEALTH-TRODE+LS	Sep 18, 1992	Substantially Equivalent	Cardiotronics, Inc.
K922563	LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR)	Jul 28, 1992	Substantially Equivalent	Raco Products Co.
K920990	LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR)	Jul 06, 1992	Substantially Equivalent	Raco Products Co.
K922227	MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE	Jun 11, 1992	Substantially Equivalent	Cardiotronics, Inc.
K922173	MODEL # 830 ST ADULT STIMULATION PADS (STERILE)	Jun 11, 1992	Substantially Equivalent	Cardiotronics, Inc.
K922172	MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)	Jun 11, 1992	Substantially Equivalent	Cardiotronics, Inc.
K921606	MODEL #125 CHILD STIMULATION PADS	May 26, 1992	Substantially Equivalent	Cardiotronics, Inc.
K912966	PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG	Feb 21, 1992	Substantially Equivalent	Physio-Control Corp.
K920086	SHOCK-PATCH ADULT DEFIBRILLATION PADS	Feb 03, 1992	Substantially Equivalent	Cardiotronics, Inc.
K913484	ZOLL D-900 DEFIBRILLATOR	Dec 16, 1991	Substantially Equivalent	Zmi Corp.
K914458	ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION	Dec 09, 1991	Substantially Equivalent	Medical Data Electronics
K914971	TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION	Dec 04, 1991	Substantially Equivalent	Nihon Kohden America, Inc.
K912621	MODEL #911 STEALTH MULTI PADS	Oct 16, 1991	Substantially Equivalent	Cardiotronics, Inc.
K911456	MODEL #110 STEALTH-TRODE CHILD DEFIB PADS	Oct 16, 1991	Substantially Equivalent	Cardiotronics, Inc.
K911455	MODEL #100 SHOCK-TRODE CHILD DEFIB PADS	Oct 16, 1991	Substantially Equivalent	Cardiotronics, Inc.
K911662	MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS	Oct 10, 1991	Substantially Equivalent	Marquette Electronics, Inc.
K911402	MODEL #350 SHOCK-PLATE DEFIB ADAPTOR	Oct 03, 1991	Substantially Equivalent	Cardiotronics, Inc.
K911604	MDPHONE CELLULAR + RESCUE (DEFIB SYSTEM)	Sep 23, 1991	Substantially Equivalent	Medphone Corp.
K911665	ESCORT 300 SERIES	Aug 29, 1991	Substantially Equivalent	Medical Data Electronics
K912587	K-FREE	Jul 30, 1991	Substantially Equivalent	Katecho, Inc.
K910634	DC200 DEFIBRILLATOR	Jul 24, 1991	Substantially Equivalent	Siemens Burdick, Inc.
K910144	12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON	Jul 17, 1991	Substantially Equivalent	Physio-Control Corp.
K910754	MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION	May 08, 1991	Substantially Equivalent	Hewlett-Packard Co.
K905065	DEFIBRILLATOR LEAD ADAPTER	Apr 12, 1991	Substantially Equivalent	Spacelabs, Inc.
K902288	MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR	Feb 25, 1991	Substantially Equivalent	Physio-Control Corp.
K904466	MODEL #250 DEFIB CABLE	Jan 30, 1991	Substantially Equivalent	Cardiotronics, Inc.
K902782	SERIES 1500 RESPONDER	Jan 18, 1991	Substantially Equivalent	Marquette Electronics, Inc.
K896903	FIRST MEDIC MODEL 510	Dec 27, 1990	Substantially Equivalent	Spacelabs, Inc.
K905510	LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED	Dec 20, 1990	Substantially Equivalent	Physio-Control Corp.
K904462	MODEL #210 STEALTH DEFIB PADS	Dec 03, 1990	Substantially Equivalent	Cardiotronics, Inc.
K903018	MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002	Dec 03, 1990	Substantially Equivalent	Medtronic Andover Medical, Inc.
K902478	LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR	Oct 31, 1990	Substantially Equivalent	Physio-Control Corp.
K902429	MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE	Sep 27, 1990	Substantially Equivalent	Laerdal Mfg. Corp.
K903657	MODEL 610 MODIFIED	Sep 04, 1990	Substantially Equivalent	First Medical Devices Corp.
K902590	THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT	Jul 18, 1990	Substantially Equivalent	Marquette Electronics, Inc.
K895379	LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)	Feb 26, 1990	Substantially Equivalent	Physio-Control Corp.
K900169	MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE	Jan 26, 1990	Substantially Equivalent	Laerdal Mfg. Corp.
K895533	LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER	Jan 26, 1990	Substantially Equivalent	Matrix Medica, Inc.
K895662	DEFIB K-PADS	Jan 18, 1990	Substantially Equivalent	Katecho, Inc.
K895009	GEL-TAC(R)	Dec 13, 1989	Substantially Equivalent	Padeco, Inc.
K894356	DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB.	Dec 13, 1989	Substantially Equivalent	Phycon
K895651	MARQUETTE 1200 DEFIBRILLATION PADS	Dec 12, 1989	Substantially Equivalent	Marquette Electronics, Inc.
K894355	DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.	Dec 12, 1989	Substantially Equivalent	Phycon
K895185	FIRST MEDIC MODEL 610P	Oct 27, 1989	Substantially Equivalent	First Medical Devices Corp.
K895113	COORDINATOR	Oct 26, 1989	Substantially Equivalent	Cardiotronics, Inc.
K895032	ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES	Oct 12, 1989	Substantially Equivalent	Zmi Corp.
K893990	P POLYMER	Oct 12, 1989	Substantially Equivalent	Pace West
K891122	DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE.	Sep 13, 1989	Substantially Equivalent	Big Valley Medical
K893403	MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE	Aug 03, 1989	Substantially Equivalent	Hewlett-Packard Co.
K890079	LIFEPAK 10 DEFIBRILLATOR/MONITOR	Feb 23, 1989	Substantially Equivalent	Physio-Control Corp.
K885186	HEARTSTART 2000 DEFIBRILLATION ELECTRODE	Feb 23, 1989	Substantially Equivalent	Laerdal Mfg. Corp.
K883617	LIFEPAK 50 MONITOR/DEFIBRILLATOR	Dec 28, 1988	Substantially Equivalent	Physio-Control Corp.
K882235	POLY-TAC	Oct 05, 1988	Substantially Equivalent	Cardiovascular Group, Inc.
K882337	MODEL #825 ADULT STIM. PADS POLYMER TYPE	Aug 02, 1988	Substantially Equivalent	Cardiotronics, Inc.
K880575	CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES	Aug 02, 1988	Substantially Equivalent	Nihon Kohden America, Inc.
K881153	LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR	Jul 27, 1988	Substantially Equivalent	Physio-Control Corp.
K874204	450SLL DEFIBRILLATOR	Jan 28, 1988	Substantially Equivalent	Medical Research Laboratories, Inc.
K874697	STRATUM D	Dec 15, 1987	Substantially Equivalent	Alternative Design Systems, Inc.
K864257	TELEPHONE DEFIBRILLATOR SYSTEM	Nov 27, 1987	Substantially Equivalent	Medphone Corp.
K874091	360D DC DEFIBRILLATOR	Nov 23, 1987	Substantially Equivalent	Medac, Inc.
K872793	DP-700 NIKMAN DEFIB-PADS	Oct 09, 1987	Substantially Equivalent	Nikomed U.S.A., Inc.
K871224	FAST-PATCH(TM)	May 20, 1987	Substantially Equivalent	Physio-Control Corp.
K871136	HEARTSTART 2000, MANUAL DEFIBRILLATOR	May 12, 1987	Substantially Equivalent	First Medical Devices Corp.
K871135	HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE	May 12, 1987	Substantially Equivalent	First Medical Devices Corp.
K863899	K-STIK DEFIBRILLATION PADS	Nov 12, 1986	Substantially Equivalent	Katecho, Inc.
K863405	CARDIOLIFE TEC 7200	Oct 31, 1986	Substantially Equivalent	Nihon Kohden America, Inc.
K863404	CARDIOLIFE TEC 7100	Oct 31, 1986	Substantially Equivalent	Nihon Kohden America, Inc.
K863303	MODEL 617D	Sep 05, 1986	Substantially Equivalent	Quinton, Inc.
K855082	DEFIB-PADS	Mar 31, 1986	Substantially Equivalent	Conmedcorp
K854175	DEFIGARD 2000	Jan 13, 1986	Substantially Equivalent	Odam
K854307	KONTRON DEFIBRILLATOR 7501	Dec 04, 1985	Substantially Equivalent	Kontron Instruments, Inc.
K852905	CR 280/45, CR281/4 DEFIBRILLATOR	Nov 05, 1985	Substantially Equivalent	Cardiac Recorders, Ltd.
K853439	MODEL 43130A DEFIBRILLATOR	Oct 11, 1985	Substantially Equivalent	Hewlett-Packard Co.
K853354	MEDIC 4	Oct 11, 1985	Substantially Equivalent	Kone Instruments, Inc.
K852808	CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)	Sep 16, 1985	Substantially Equivalent	Cardiac Recorders, Ltd.
K852799	2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR)	Sep 16, 1985	Substantially Equivalent	Cardiac Recorders, Ltd.
K851485	DEFI 502	Aug 29, 1985	Substantially Equivalent	Robert Bosch Corp.
K851924	LITEGUARD 9	Aug 06, 1985	Substantially Equivalent	Temtech , Ltd.
K851931	DEFI 2	Aug 05, 1985	Substantially Equivalent	S & W Medico Teknik
K850618	FC-700 DEFIBRILLATOR	Apr 19, 1985	Substantially Equivalent	Fukuda Denshi USA, Inc.
K851092	PORTABLE DEFIBRILLATOR/MONITOR ED 425	Apr 10, 1985	Substantially Equivalent	Honeywell, Inc.
K844740	MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT	Feb 12, 1985	Substantially Equivalent	Hewlett-Packard Co.
K844103	CARDIOPAC DEFIBRILLATOR 444	Jan 18, 1985	Substantially Equivalent	Birtcher Corp.
K844447	M/D4 W/CHARGER (CARDIOPAC 3M11)	Jan 14, 1985	Substantially Equivalent	Datascope Corp.
K832833	PERSONAL DEFIBRILLATOR	Oct 26, 1984	Substantially Equivalent	Physio-Control, Inc.
K843396	LS-260G MONITOR/RECORDER & DEFIBILLATOR	Oct 19, 1984	Substantially Equivalent	Life Science Instrumentation, Inc.
K843229	LIFEPAK 200	Oct 18, 1984	Substantially Equivalent	Physio-Control Corp.
K842624	LIFEPAK 8	Oct 18, 1984	Substantially Equivalent	Physio-Control Corp.
K842667	EXTERNAL PEDIATRIC DEFIBRILLATOR PADDLE	Aug 27, 1984	Substantially Equivalent	Marquette Electronics, Inc.
K842312	SERVOCARD SCP-840	Aug 27, 1984	Substantially Equivalent	Litton Datamedix
K842235	SERVOCARD DEFIBRILLATOR SCP-851	Aug 27, 1984	Substantially Equivalent	Litton Datamedix
K840900	PORTA PAK 90	Jun 11, 1984	Substantially Equivalent	Medical Research Laboratories, Inc.
K840258	TEC-3500 DEFIBRILLATOR	May 23, 1984	Substantially Equivalent	Nihon Kohden America, Inc.
K840246	MINI-DEFIBRILLATOR 280/4	Apr 17, 1984	Substantially Equivalent	Life Science Instrumentation, Inc.
K840167	PORTABLE DEFIBRILLATOR	Feb 04, 1984	Substantially Equivalent	Honeywell, Inc.
K833751	PORTA PULSE III #D320	Jan 11, 1984	Substantially Equivalent	Medical Research Laboratories, Inc.
K832827	CORPULS 300	Nov 03, 1983	Substantially Equivalent	Automated Medical Products, Inc.
K831696	PORTABLE DEFIBRILLATOR MONITOR 74DRK	Nov 03, 1983	Substantially Equivalent	Honeywell, Inc.
K831056	DEFIBRILLATOR VPD 545	Apr 28, 1983	Substantially Equivalent	Life Science Instrumentation, Inc.
K822617	VPD540 DEFIBRILLATOR	Apr 28, 1983	Substantially Equivalent	Life Science Instrumentation, Inc.
K823933	MINIDEF (OR DEFIPORT	Apr 12, 1983	Substantially Equivalent	Odam
K823931	DEFIGARD M(OR DEFISCOPE M	Apr 12, 1983	Substantially Equivalent	Odam
K823828	THERACARD 400	Mar 17, 1983	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K823268	MODEL 78670A	Jan 26, 1983	Substantially Equivalent	Hewlett-Packard Co.
K822961	PORTA FIB III	Nov 01, 1982	Substantially Equivalent	Narco Scientific
K822294	VPD-261 DEFIBRILLATOR MONITOR	Aug 31, 1982	Substantially Equivalent	Life Science Instrumentation, Inc.
K813471	LINE POWERED LOW ENERGY DEFIBRILLATOR II	Dec 29, 1981	Substantially Equivalent	Narco Scientific
K812586	KANTRON 504 HEARTSTATION	Dec 29, 1981	Substantially Equivalent	Kantron Cardiovascular, Inc.
K812520	280/4 MINI-DEFIBRILLATOR	Sep 25, 1981	Substantially Equivalent	Life Science Instrumentation, Inc.
K812519	2000 SERIES PORTABLE RESUSCITATION SYST.	Sep 25, 1981	Substantially Equivalent	Life Science Instrumentation, Inc.
K812317	DEFIBRILLATOR/MONITOR	Sep 21, 1981	Substantially Equivalent	Hewlett-Packard Co.
K811638	DATASCOPE INTERNAL DEFIBRILLATOR PADDLES	Jul 10, 1981	Substantially Equivalent	Datascope Corp.
K810237	PORTABLE, BATTERY OPERATED DEFIBRILLATOR	Feb 19, 1981	Substantially Equivalent	Honeywell, Inc.
K801544	PORTA-FIB LPD	Jul 14, 1980	Substantially Equivalent	Narco Bio-Systems
K800937	R2 PLATE TYPE CABLE-ADAPTOR #S 175,176	May 23, 1980	Substantially Equivalent	R2 Corp.
K800936	R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171	May 23, 1980	Substantially Equivalent	R2 Corp.
K781678	DEFIBRILLATOR, MARK II	Dec 12, 1978	Substantially Equivalent	Ipco Corp.
K780416	PANTRIDGE MK III DEFIBRILLATOR/MONITOR	Apr 21, 1978	Substantially Equivalent	Ipco Corp.