Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- DRKDc-Defibrillator, High Energy, (Including Paddles)3Product Code
- DRLTester, Defibrillator2Product Code
- DRMCompressor, Cardiac, External2Product Code
- DRNDevice, Counter-Pulsating, External2Product Code
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)2Product Code
- DRPTourniquet, Automatic Rotating2Product Code
- DWJSystem, Thermal Regulating2Product Code
- DXECatheter, Embolectomy2Product Code
- DXFCatheter, Septostomy2Product Code
- JOWSleeve, Limb, Compressible2Product Code
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)2Product Code
- K203231Switched Internal Paddles2Cleared 510(K)
- K200849Tempus LS - Manual2Cleared 510(K)
- K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors2Cleared 510(K)
- K150349Rapid Hair Removal Pads2Cleared 510(K)
- K140502ZOLL E SERIES ALS2Cleared 510(K)
- K103651CARDIOMED2Cleared 510(K)
- K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC2Cleared 510(K)
- K103334CARDIO MED2Cleared 510(K)
- K103159CARDIO MED MODEL A102, H104, O101, P103, AND Z1002Cleared 510(K)
- K102468ZOLL PROPAQ MD2Cleared 510(K)
- K100654ZOLL PROPAQ MD2Cleared 510(K)
- K081442HEART SYNC PEDIATRIC, MODEL PED-1002Cleared 510(K)
- K081574ZOLL R SERIES2Cleared 510(K)
- K042302ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE2Cleared 510(K)
- K032691ZOLL AUTOCLAVABLE INTERNAL HANDLES2Cleared 510(K)
- K030417DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES2Cleared 510(K)
- K011461ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR2Cleared 510(K)
- K012274MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER2Cleared 510(K)
- K993205BOOKER BOX, MODEL PAD 50102Cleared 510(K)
- K982896ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP92Cleared 510(K)
- K971436NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES2Cleared 510(K)
- K971355NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES2Cleared 510(K)
- K971194NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES2Cleared 510(K)
- K970481V22Cleared 510(K)
- K963781ZOLL AUTOCLAVABLE INTERNAL HANDLES2Cleared 510(K)
- K964469700-F SERIES STIMULATION ELECTRODES2Cleared 510(K)
- K962551CARDIOSERV S2Cleared 510(K)
- K951110CARDIO SERV2Cleared 510(K)
- K952085DPD DEFIBRILLATOR2Cleared 510(K)
- K940842UNIPOWER RECHARGEABLE BATTERY PACK2Cleared 510(K)
- K941995NCE REPLACEMENT BATTERIES2Cleared 510(K)
- K935083PEDIATRIC DEFIB K-PADS2Cleared 510(K)
- K935111UNIPOWERR RECHARGEABLE BATTERY PACK2Cleared 510(K)
- K922315VITAL-COMBO(R)2Cleared 510(K)
- K934508BATTERY PACK# S1024NC2Cleared 510(K)
- K934015RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB2Cleared 510(K)
- K931266BATTERY PACK #1012NC2Cleared 510(K)
- K935674LIFEPAK 9 DEFIBRILLATOR/MONITOR2Cleared 510(K)
- K931787ZOLL PD 53002Cleared 510(K)
- K931805ZOLL PD 5200C ADULT SOLID GEL MULTI-FUNCTION ELECT2Cleared 510(K)
- K9318035200 ADULT SOLID GEL MULTI-FUNCTION ELECTRODES2Cleared 510(K)
- K931804ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTRO2Cleared 510(K)
- K921666CARDIAC THERAPHY SYSTEM SCP 9002Cleared 510(K)
- K930548DPD DEFIBRILLATOR2Cleared 510(K)
- K931053LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER2Cleared 510(K)
- K921765PRIMEDIC DEFIBRILLATORS-N/B2Cleared 510(K)
- K921487MARQUETTE SERIES 360 DEFIBRILLATOR2Cleared 510(K)
- K923864BATTERY PACK2Cleared 510(K)
- K923297MODEL #340 STEALTH-TRODE+LS2Cleared 510(K)
- K922563LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR)2Cleared 510(K)
- K920990LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR)2Cleared 510(K)
- K922227MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE2Cleared 510(K)
- K922173MODEL # 830 ST ADULT STIMULATION PADS (STERILE)2Cleared 510(K)
- K922172MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)2Cleared 510(K)
- K921606MODEL #125 CHILD STIMULATION PADS2Cleared 510(K)
- K912966PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG2Cleared 510(K)
- K920086SHOCK-PATCH ADULT DEFIBRILLATION PADS2Cleared 510(K)
- K913484ZOLL D-900 DEFIBRILLATOR2Cleared 510(K)
- K914458ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION2Cleared 510(K)
- K914971TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION2Cleared 510(K)
- K912621MODEL #911 STEALTH MULTI PADS2Cleared 510(K)
- K911456MODEL #110 STEALTH-TRODE CHILD DEFIB PADS2Cleared 510(K)
- K911455MODEL #100 SHOCK-TRODE CHILD DEFIB PADS2Cleared 510(K)
- K911662MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS2Cleared 510(K)
- K911402MODEL #350 SHOCK-PLATE DEFIB ADAPTOR2Cleared 510(K)
- K911604MDPHONE CELLULAR + RESCUE (DEFIB SYSTEM)2Cleared 510(K)
- K911665ESCORT 300 SERIES2Cleared 510(K)
- K912587K-FREE2Cleared 510(K)
- K910634DC200 DEFIBRILLATOR2Cleared 510(K)
- K91014412-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON2Cleared 510(K)
- K910754MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION2Cleared 510(K)
- K905065DEFIBRILLATOR LEAD ADAPTER2Cleared 510(K)
- K902288MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR2Cleared 510(K)
- K904466MODEL #250 DEFIB CABLE2Cleared 510(K)
- K902782SERIES 1500 RESPONDER2Cleared 510(K)
- K896903FIRST MEDIC MODEL 5102Cleared 510(K)
- K905510LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED2Cleared 510(K)
- K904462MODEL #210 STEALTH DEFIB PADS2Cleared 510(K)
- K903018MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-0022Cleared 510(K)
- K902478LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR2Cleared 510(K)
- K902429MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE2Cleared 510(K)
- K903657MODEL 610 MODIFIED2Cleared 510(K)
- K902590THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT2Cleared 510(K)
- K895379LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)2Cleared 510(K)
- K900169MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE2Cleared 510(K)
- K895533LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER2Cleared 510(K)
- K895662DEFIB K-PADS2Cleared 510(K)
- K895009GEL-TAC(R)2Cleared 510(K)
- K894356DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB.2Cleared 510(K)
- K895651MARQUETTE 1200 DEFIBRILLATION PADS2Cleared 510(K)
- K894355DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.2Cleared 510(K)
- K895185FIRST MEDIC MODEL 610P2Cleared 510(K)
- K895113COORDINATOR2Cleared 510(K)
- K895032ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES2Cleared 510(K)
- K893990P POLYMER2Cleared 510(K)
- K891122DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE.2Cleared 510(K)
- K893403MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE2Cleared 510(K)
- K890079LIFEPAK 10 DEFIBRILLATOR/MONITOR2Cleared 510(K)
- K885186HEARTSTART 2000 DEFIBRILLATION ELECTRODE2Cleared 510(K)
- K883617LIFEPAK 50 MONITOR/DEFIBRILLATOR2Cleared 510(K)
- K882235POLY-TAC2Cleared 510(K)
- K882337MODEL #825 ADULT STIM. PADS POLYMER TYPE2Cleared 510(K)
- K880575CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES2Cleared 510(K)
- K881153LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR2Cleared 510(K)
- K874204450SLL DEFIBRILLATOR2Cleared 510(K)
- K874697STRATUM D2Cleared 510(K)
- K864257TELEPHONE DEFIBRILLATOR SYSTEM2Cleared 510(K)
- K874091360D DC DEFIBRILLATOR2Cleared 510(K)
- K872793DP-700 NIKMAN DEFIB-PADS2Cleared 510(K)
- K871224FAST-PATCH(TM)2Cleared 510(K)
- K871136HEARTSTART 2000, MANUAL DEFIBRILLATOR2Cleared 510(K)
- K871135HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE2Cleared 510(K)
- K863899K-STIK DEFIBRILLATION PADS2Cleared 510(K)
- K863404CARDIOLIFE TEC 71002Cleared 510(K)
- K863405CARDIOLIFE TEC 72002Cleared 510(K)
- K863303MODEL 617D2Cleared 510(K)
- K855082DEFIB-PADS2Cleared 510(K)
- K854175DEFIGARD 20002Cleared 510(K)
- K854307KONTRON DEFIBRILLATOR 75012Cleared 510(K)
- K852905CR 280/45, CR281/4 DEFIBRILLATOR2Cleared 510(K)
- K853439MODEL 43130A DEFIBRILLATOR2Cleared 510(K)
- K853354MEDIC 42Cleared 510(K)
- K852808CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)2Cleared 510(K)
- K8527992006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR)2Cleared 510(K)
- K851485DEFI 5022Cleared 510(K)
- K851924LITEGUARD 92Cleared 510(K)
- K851931DEFI 22Cleared 510(K)
- K850618FC-700 DEFIBRILLATOR2Cleared 510(K)
- K851092PORTABLE DEFIBRILLATOR/MONITOR ED 4252Cleared 510(K)
- K844740MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT2Cleared 510(K)
- K844103CARDIOPAC DEFIBRILLATOR 4442Cleared 510(K)
- K844447M/D4 W/CHARGER (CARDIOPAC 3M11)2Cleared 510(K)
- K832833PERSONAL DEFIBRILLATOR2Cleared 510(K)
- K843396LS-260G MONITOR/RECORDER & DEFIBILLATOR2Cleared 510(K)
- K843229LIFEPAK 2002Cleared 510(K)
- K842624LIFEPAK 82Cleared 510(K)
- K842667EXTERNAL PEDIATRIC DEFIBRILLATOR PADDLE2Cleared 510(K)
- K842312SERVOCARD SCP-8402Cleared 510(K)
- K842235SERVOCARD DEFIBRILLATOR SCP-8512Cleared 510(K)
- K840900PORTA PAK 902Cleared 510(K)
- K840258TEC-3500 DEFIBRILLATOR2Cleared 510(K)
- K840246MINI-DEFIBRILLATOR 280/42Cleared 510(K)
- K840167PORTABLE DEFIBRILLATOR2Cleared 510(K)
- K833751PORTA PULSE III #D3202Cleared 510(K)
- K832827CORPULS 3002Cleared 510(K)
- K831696PORTABLE DEFIBRILLATOR MONITOR 74DRK2Cleared 510(K)
- K831056DEFIBRILLATOR VPD 5452Cleared 510(K)
- K822617VPD540 DEFIBRILLATOR2Cleared 510(K)
- K823931DEFIGARD M(OR DEFISCOPE M2Cleared 510(K)
- K823933MINIDEF (OR DEFIPORT2Cleared 510(K)
- K823828THERACARD 4002Cleared 510(K)
- K823268MODEL 78670A2Cleared 510(K)
- K822961PORTA FIB III2Cleared 510(K)
- K822294VPD-261 DEFIBRILLATOR MONITOR2Cleared 510(K)
- K813471LINE POWERED LOW ENERGY DEFIBRILLATOR II2Cleared 510(K)
- K812586KANTRON 504 HEARTSTATION2Cleared 510(K)
- K8125192000 SERIES PORTABLE RESUSCITATION SYST.2Cleared 510(K)
- K812520280/4 MINI-DEFIBRILLATOR2Cleared 510(K)
- K812317DEFIBRILLATOR/MONITOR2Cleared 510(K)
- K811638DATASCOPE INTERNAL DEFIBRILLATOR PADDLES2Cleared 510(K)
- K810237PORTABLE, BATTERY OPERATED DEFIBRILLATOR2Cleared 510(K)
- K801544PORTA-FIB LPD2Cleared 510(K)
- K800937R2 PLATE TYPE CABLE-ADAPTOR #S 175,1762Cleared 510(K)
- K800936R2 PADDLE TYPE CABLE-ADAPTOR #S 170,1712Cleared 510(K)
- K781678DEFIBRILLATOR, MARK II2Cleared 510(K)
- K780416PANTRIDGE MK III DEFIBRILLATOR/MONITOR2Cleared 510(K)
- LHXTrousers, Anti-Shock2Product Code
- LIXAid, Cardiopulmonary Resuscitation2Product Code
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous2Product Code
- MKJAutomated External Defibrillators (Non-Wearable)3Product Code
- MMXDevice, Percutaneous Retrieval2Product Code
- MPCAtrial Defibrillator3Product Code
- MPDAuxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator2Product Code
- MPEAuxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker2Product Code
- NSAOver-The-Counter Automated External Defibrillator3Product Code
- NZEHyperthermia Monitor2Product Code
- PJBCatheter Remote Control System2Product Code
- PLAEsophageal Thermal Regulation And Gastric Suctioning Device2Product Code
- PMJCpr Aid Feedback Device (No Software)2Product Code
- PMKCpr Aid Device Without Feedback1Product Code
- PPSSleeve, Head And Neck, Compressible2Product Code
- QEWPeripheral Mechanical Thrombectomy With Aspiration2Product Code
- QEXCoronary Mechanical Thrombectomy With Aspiration2Product Code
- QEYMechanical Thrombolysis Catheter2Product Code
- QEZAspiration Thrombectomy Catheter2Product Code
- QLZSeptostomy Catheter, Reprocessed2Product Code
- QMSAdjunctive Open Loop Fluid Therapy Recommender2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PRIMEDIC DEFIBRILLATORS-N/B
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K921765
- 510(k) Type
- Traditional
- Applicant
- METRONIC ELECTRONIC GMBH
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/3/1993
- Days to Decision
- 323 days
- Submission Type
- Summary