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
- LHXTrousers, Anti-Shock2Product Code
- LIXAid, Cardiopulmonary Resuscitation2Product Code
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous2Product Code
- MKJAutomated External Defibrillators (Non-Wearable)3Product Code
- P200005TZ Medical Defibrillation Electrodes, Accessory Cables, and ConnectorsAPPRPMA Approval
- P200007HeartSync Multifunction Disposable Single-Use AED Defibrillator PadsAPPRPMA Approval
- P210015Avive Automated External Defibrillator (AED) SystemAPPRPMA Approval
- P200004ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode AdaptersAPPRPMA Approval
- P190013AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)APPRPMA Approval
- P190007Cardinal Health Multifunctional Defibrillation ElectrodeAPPRPMA Approval
- P180028HeartStart FRx DefibrillatorAPPRPMA Approval
- P160028Philips HeartStart FR3 DefibrillatorAPPRPMA Approval
- P170018LIFEPAK® CR2 DefibrillatorAPPRPMA Approval
- P160033Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3APPRPMA Approval
- P160032Defibtech Automated External Defibrillator (AED) Systems3PMA Approval
- P160015AED 3, AED Plus3PMA Approval
- P160022X Series, AED Pro, Propaq MD3PMA Approval
- P160026LIFEPAK Automated External Defibrillators (AEDs)3PMA Approval
- P160012Infant/Child Reduced Energy Defibrillation Electrodes3PMA Approval
- P160015Zoll AED 3 and Zoll AED 3 Automatic3PMA Approval
- P160022ZOLL AED 3 BLS Device3PMA Approval
- P160026LIFEPAK 15 Monitor/Defibrillator3PMA Approval
- P160026LIFEPAK 15 Monitor/Defibrillator3PMA Approval
- P180028HeartStart FRx Defibrillator3PMA Approval
- P180028HeartStart FRx Defibrillator3PMA Approval
- P160028HeartStart FR3 Defibrillator3PMA Approval
- P160033Powerheart G5 AED3PMA Approval
- P160032Defibtech's Automated External Defibrillator (AED) System3PMA Approval
- P160008samaritan Public Access Automated External Defibrillators and Accessories3PMA Approval
- P170018LIFEPAK® CR2 Defibrillator3PMA Approval
- P160022X Series Advanced Devices3PMA Approval
- P160026LIFEPAK® 1000 Defibrillator3PMA Approval
- P160026LIFEPAK Automated External Defibrillator (AED)3PMA Approval
- P180028HeartStart FRx Defibrillator3PMA Approval
- P160022X Series, R Series, Propaq MD, and AED Pro3PMA Approval
- P160026LIFEPAK 15 Monitor/Defibrillator and LIFEPAK 20e Defibrillator/Monitor3PMA Approval
- P160015ZOLL AED 3 and ZOLL AED 3 Automatic3PMA Approval
- P160022ZOLL AED 3 BLS3PMA Approval
- P180028HeartStart FRx Defibrillator3PMA Approval
- P160015AED Plus3PMA Approval
- P160032Defibtech Automated External Defibrillator (AED) Systems3PMA Approval
- P170018LIFEPAK CR2 Automated External Defibrillator3PMA Approval
- P180028HeartStart FRx Defibrillator3PMA Approval
- P160033Powerheart® G5 AED3PMA Approval
- P190013AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)3PMA Approval
- P160028Philips HeartStart FR3 Defibrillator3PMA Approval
- P160022X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™3PMA Approval
- P160022R Series Device3PMA Approval
- P160015ZOLL CPR Uni-padz3PMA Approval
- P160015ZOLL Stat-padz II Electrodes and ZOLL Pedi-padz II Electrodes3PMA Approval
- P160015Zoll AED 33PMA Approval
- P160028HeartStart FR3 Defibrillator3PMA Approval
- P180028HeartStart FRx Defibrillator3PMA Approval
- P160022X Series, R Series, and AED Pro3PMA Approval
- P160008samaritan Public Access Automated External Defibrillators and Accessories3PMA Approval
- P160032Defibtech Automated External Defibrillator (AED) Systems3PMA Approval
- P160032Defibtech Automated External Defibrillator (AED) Systems3PMA Approval
- P170018LIFEPAK CR2 Defibrillator3PMA Approval
- P160008HeartSine samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P, and SAM 450P) and Accessories3PMA Approval
- P160032Defibtech Automated External Defibrillator (AED) Systems3PMA Approval
- P160015ZOLL AED Plus and ZOLL Fully Automatic AED Plus3PMA Approval
- P170018LIFEPAK CR2 Defibrillator3PMA Approval
- P170018LIFEPAK CR2 Automated External Defibrillator3PMA Approval
- P160022X Series, Propaq MD, and R Series3PMA Approval
- P160022X Series and Propaq MD3PMA Approval
- P160022AED 3 BLS3PMA Approval
- P170018LIFEPAK CR2 Automated External Defibrillator3PMA Approval
- P160026LIFEPAK Automated External Defibrillators3PMA Approval
- P170018LIFEPAK CR2 Defibrillator3PMA Approval
- P160022ZOLL X Series, Propaq MD, and X Series Advanced3PMA Approval
- P180028HeartStart FRx Defibrillator3PMA Approval
- P190007Cardinal Health Multifunctional Defibrillation Electrode3PMA Approval
- P180028HeartStart FRx Defibrillator3PMA Approval
- P160028HeartStart FR3 Defibrillator3PMA Approval
- P160026LIFEPAK Automated External Defibrillators (AEDs)3PMA Approval
- P160026LIFEPAKAutomated External Defibrillators (AEDs)3PMA Approval
- P160008HeartSine samaritan Public Access Automated External Defibrillators and Accessories3PMA Approval
- P180028HeartStart FRx Defibrillator (861304)3PMA Approval
- P170018LIFEPAK CR2 Defibrillator3PMA Approval
- P160026LIFEPAK Automated External Defibrillators (AEDs)3PMA Approval
- P160022ZOLL R Series3PMA Approval
- P160032Lifeline/ReviveR, Lifeline/ReviveR Auto, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li3PMA Approval
- P160026LIFEPAK Automated External Defibrillators (AEDs)3PMA Approval
- P160022X Series and Propaq MD3PMA Approval
- P160015AED 3 Defibrillator with Uni-Padz3PMA Approval
- P160032Lifeline/ReviveR, Lifeline/ReviveR AUTO, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li3PMA Approval
- P170018LIFEPAK CR2 Automated External Defibrillator (AED)3PMA Approval
- P160012LIFEPAK CR Plus defibrillator and LIFEPAK EXPRESS defibrillator3PMA Approval
- P180028HeartStart FRx Defibrillator3PMA Approval
- P160028Philips HeartStart FR3 Defibrillator3PMA Approval
- P160008samaritan Public Access Automated External Defibrillators and Accessories3PMA Approval
- P160032Defibtech Automated External Defibrillator (AED) Systems3PMA Approval
- P160008samaritan Public Access Automated External Defibrillators and Accessories3PMA Approval
- P160034Powerheart G3 Pro Automated External Defibrillator3PMA Approval
- P160015AED 3 defibrillator3PMA Approval
- P160026LIFEPAK 15 monitor/defibrillator3PMA Approval
- P160026LIFEPAK Automated External Defibrillators (AEDs)3PMA Approval
- P160015AED Plus3PMA Approval
- P160026LIFEPAK Automated External Defibrillators (AEDs)3PMA Approval
- P160008HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)3PMA Approval
- P160022X Series®/Propaq MD device3PMA Approval
- P160026LIFEPAK 20e defibrillator/monitor3PMA Approval
- P160008HeartSine’s samaritan Public Access Automated External Defibrillators and Accessories3PMA Approval
- P160026LIFEPAK 20e Defibrillator/Monitor3PMA Approval
- P170018LIFEPAK® CR2 Defibrillator3PMA Approval
- P160022AED Pro Device3PMA Approval
- P160033Powerheart® G3, G3 Plus and G5 AEDs3PMA Approval
- P160034Powerheart® G3 Pro AED3PMA Approval
- P160022Zoll R Series3PMA Approval
- P160033Powerheart G5 Automated External Defibrillator3PMA Approval
- P160026LIFEPAK 1000 defibrillator3PMA Approval
- P160026LIFEPAK Automated External Defibrillators (AEDs)3PMA Approval
- P160022X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™3PMA Approval
- P160008samaritan Public Access Automated External Defibrillators3PMA Approval
- P160026LIFEPAK Automated External Defibrillators (AED)3PMA Approval
- P160026LIFEPAK® 20e defibrillator/monitor3PMA Approval
- P170018LIFEPAK CR2 Defibrillator3PMA Approval
- P160015CPR Stat-Padz Electrode and CPR-D Padz Electrode3PMA Approval
- P160026LIFEPAK 15 monitor/defibrillator3PMA Approval
- P160022X Series/Propaq MD3PMA Approval
- P160008samaritan Public Access Automated External Defibrillators and Accessories3PMA Approval
- P170018LIFEPAK® CR2 Defibrillator3PMA Approval
- P170018LIFEPAK CR2 Defibrillator3PMA Approval
- P160008HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories3PMA Approval
- P160026LIFEPAK Automated External Defibrillators (AEDs)3PMA Approval
- P170018LIFEPAK® CR2 Defibrillator3PMA Approval
- P160033Powerheart G5 AED3PMA Approval
- P160008HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)3PMA Approval
- P160033Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G33PMA Approval
- P160026LIFEPAK 15 monitor/defibrillator3PMA Approval
- P160032Defibtech Automated External Defibrillator (AED) Systems3PMA Approval
- P160034Powerheart® AED G3 Pro3PMA Approval
- P160026LIFEPAK Automated External Defibrillatorts (AEDs)3PMA Approval
- P160022Zoll X Series Device (Oridion MicroMediCO2)3PMA Approval
- P160008HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories3PMA Approval
- P160022AED 3 BLS Device3PMA Approval
- P160008samaritan Public Access Automated External Defibrillators and Accessories3PMA Approval
- P160022ZOLL R Series Device3PMA Approval
- P160026LIFEPAK 15 Monitor/Defibrillator3PMA Approval
- P160022Zoll X Series Device3PMA Approval
- P160026LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE3PMA Approval
- P160022OneStep Pacing Cable Assembly used wit R Series Device3PMA Approval
- P160022MFC-CPRD Cable Assembly used with X Series and R Series Device3PMA Approval
- P160022ZOLL X Series3PMA Approval
- P160032Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-3PMA Approval
- P160022X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™3PMA Approval
- P160012LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger3PMA Approval
- P160015AED Plus and Fully Automatic AED Plus3PMA Approval
- P160008HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)3PMA Approval
- K143714Powerheart G5 AED3Cleared 510(K)
- K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel3Cleared 510(K)
- K150055OneStep Pediatric CPR Multi-Function Electrode3Cleared 510(K)
- K142709samaritan PAD 450P3Cleared 510(K)
- K133659HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING3Cleared 510(K)
- K133239ZOLL E SERIES3Cleared 510(K)
- K142430LIFEPAK 15 monitor/defibrillator3Cleared 510(K)
- K141795BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 5003Cleared 510(K)
- K142915ZOLL X Series3Cleared 510(K)
- K142803Skintact, various other tradenames3Cleared 510(K)
- K141231ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY3Cleared 510(K)
- K141774ZOLL X SERIES3Cleared 510(K)
- K133441ONESTEP CPR II MULTI-FUNCTION ELECTRODE3Cleared 510(K)
- K133484ZOLL X SERIES3Cleared 510(K)
- K133269ZOLL X SERIES3Cleared 510(K)
- K131525SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES3Cleared 510(K)
- K122758POWERHEART G5 AED3Cleared 510(K)
- K131550HEART SYNC3Cleared 510(K)
- K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR3Cleared 510(K)
- K131494HEART SYNC3Cleared 510(K)
- K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR3Cleared 510(K)
- K123881HEARTSINE SAMARITAN PAD 350P3Cleared 510(K)
- K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST3Cleared 510(K)
- K113787DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES3Cleared 510(K)
- K122839ZOLL SUREPOWER SINGLE BAY CHARGER3Cleared 510(K)
- K121853DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES3Cleared 510(K)
- K120350EXTENDED LIFE BATTERY3Cleared 510(K)
- K120406ZOLL FULLY AUTOMATIC AED PLUS3Cleared 510(K)
- K122600LIFEPAK 1000 DEFIBRILLATOR3Cleared 510(K)
- K120907ZOLL R SERIES3Cleared 510(K)
- K120536HEART SYNC PEDIATRIC PHYSIO AED PAD3Cleared 510(K)
- K112761ZOLL PROPAQ MD3Cleared 510(K)
- K112432ZOLL X SERIES3Cleared 510(K)
- K110825PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES3Cleared 510(K)
- K111693PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR3Cleared 510(K)
- K111594ZOLL E SERIES3Cleared 510(K)
- K102496POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS3Cleared 510(K)
- K110978ONESTEP PEDIATRIC MFE'S3Cleared 510(K)
- K110742ONESTEP ADULT MULTI-FUNCTION ELECTRODE3Cleared 510(K)
- K110526ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE3Cleared 510(K)
- K103567LIFEPAK 15 MONITOR/DEFIBRILLATOR3Cleared 510(K)
- K110361ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE3Cleared 510(K)
- K110168ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE3Cleared 510(K)
- K110154ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE3Cleared 510(K)
- K103186SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES3Cleared 510(K)
- K102972LIFEPAK 123Cleared 510(K)
- K100565DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-03253Cleared 510(K)
- K091561ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE3Cleared 510(K)
- K092391MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED3Cleared 510(K)
- K091265ZOLL E SERIES WITH CPRREADYCHARGE3Cleared 510(K)
- K092598ZOLL E SERIES WITH SPCO/SPMET OPTION3Cleared 510(K)
- K090989ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES3Cleared 510(K)
- K091943POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A3Cleared 510(K)
- K091548AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A3Cleared 510(K)
- K081259DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES3Cleared 510(K)
- K082937LIFEPAK 15 MONITOR/DEFIBRILLATOR3Cleared 510(K)
- K081081ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING3Cleared 510(K)
- K0820909131 DEFIBRILLATION ELECTRODES3Cleared 510(K)
- K081828ZOLL R SERIES BLS DEFIBRILLATOR3Cleared 510(K)
- K080903ZOLL E SERIES WITH INTIBATION ASSIST OPTION3Cleared 510(K)
- K082861AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L5613Cleared 510(K)
- K081371SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL3Cleared 510(K)
- K073089LIFEPAK 20E3Cleared 510(K)
- K072923ZOLL E SERIES DEFIBRILLATOR3Cleared 510(K)
- K080232ZOLL E SERIES 12SL, ANALYSIS OPTION3Cleared 510(K)
- K073716LIFE+CEL OR LIFECEL BATTERY3Cleared 510(K)
- K080421HEART SYNC, MODELS C-100 AND T-1003Cleared 510(K)
- K072812PHILIPS HEARTSTART SMARTPADS III3Cleared 510(K)
- K072596LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L5003Cleared 510(K)
- K062970I-PAD3Cleared 510(K)
- K072430ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE3Cleared 510(K)
- K072233SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS3Cleared 510(K)
- K071025ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO3Cleared 510(K)
- K070455ZOLL E SERIES WITH SEE-THRU CPR3Cleared 510(K)
- K062537ZOLL M SERIES WITH REAL CPR HELP3Cleared 510(K)
- K063510LIFEPAK 12 DEFIBRILLATOR/MONITOR3Cleared 510(K)
- K063375HEARTSTART MRX, MODELS M3535A OR M3536A3Cleared 510(K)
- K063119LIFEPAK 20 DEFIBRILLATOR/ MONITOR3Cleared 510(K)
- K062177ZOLL E SERIES WITH REAL CPR HELP3Cleared 510(K)
- K052465REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 3513Cleared 510(K)
- K062233HEARTSTART MRX MONITOR/DEFIBRILLATOR3Cleared 510(K)
- K060559ZOLL R SERIES DEFIBRILLATOR3Cleared 510(K)
- K061707HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS3Cleared 510(K)
- K060934MODIFICATION TO POWERHEART ECD3Cleared 510(K)
- K052057LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR3Cleared 510(K)
- K052316POWERHEART ECD3Cleared 510(K)
- K042404LIFEPAK, MODEL 10003Cleared 510(K)
- K052161POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)3Cleared 510(K)
- K051632PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A3Cleared 510(K)
- K051134HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A3Cleared 510(K)
- K051475ZOLL M SERIES 12SL ANALYSIS OPTION3Cleared 510(K)
- K051076ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES3Cleared 510(K)
- K042007ZOLL E SERIES DEFIBRILLATOR3Cleared 510(K)
- K050004PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 8613043Cleared 510(K)
- K041892ZOLL AED PRO EXTERNAL DEFIBRILLATOR3Cleared 510(K)
- K042417ZOLL M SERIES ETC02 LOFLO OPTION3Cleared 510(K)
- K040479PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-203Cleared 510(K)
- K041883SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 213Cleared 510(K)
- K042088SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-3013Cleared 510(K)
- K040637POWERHEART AED G3 PRO3Cleared 510(K)
- K041459LIFEPAK 12 DEFIBRILLATOR/MONITOR3Cleared 510(K)
- K040438POWERHEART AED G3A3Cleared 510(K)
- K033896DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P3Cleared 510(K)
- K041067HEARTSINE SAMARITAN PAD3Cleared 510(K)
- K033642SMARTLANK WIRELESS, MODEL 0019703Cleared 510(K)
- K033474ZOLL AED PLUS3Cleared 510(K)
- K040404HEARTSTART MRX, MODEL M3535A3Cleared 510(K)
- K040775LIFEPAK 123Cleared 510(K)
- K040256PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-10053Cleared 510(K)
- K040056BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-903Cleared 510(K)
- K033771BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR3Cleared 510(K)
- K032421AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE3Cleared 510(K)
- K032051BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P3Cleared 510(K)
- K033144DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES3Cleared 510(K)
- K033275LIFEPAK 12, 20, 500, CR PLUS3Cleared 510(K)
- K032439ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)3Cleared 510(K)
- K031187HEARTSTART MRX, MODEL M3535A3Cleared 510(K)
- K030898MOBILE BATTERY SERVICE STATION (MBSS)3Cleared 510(K)
- K031987POWERHEART AED G3, MODEL 93003Cleared 510(K)
- K023854SAMARITAN AED, MODEL SAM-013Cleared 510(K)
- K022929PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/92103Cleared 510(K)
- K022732INFANT/CHILD REDUCED ENERGY ELECTRODES3Cleared 510(K)
- K020715PHILIPS M5066A AND M5068A3Cleared 510(K)
- K022210MULTIFUNCTIONAL ELECTRODE MODELS 9640, 96503Cleared 510(K)
- K020984ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS3Cleared 510(K)
- K021453HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A3Cleared 510(K)
- K021168JUMP START, MODEL 9703003Cleared 510(K)
- K013896SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA3Cleared 510(K)
- K020743PADPRO, MODEL 25023Cleared 510(K)
- K020203PADPRO MODEL #25163Cleared 510(K)
- K011541ZOLL PAD WITH CPR AID3Cleared 510(K)
- K011388ZOLL PAD3Cleared 510(K)
- K020288PADPRO, MODEL 26033Cleared 510(K)
- K011901FIRSTSAVE STAR BIPHASIC, MODEL 9210/92003Cleared 510(K)
- K012766PORTABLE INTENSIVE CARE UNIT3Cleared 510(K)
- K014209PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS3Cleared 510(K)
- K014157HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A3Cleared 510(K)
- K013425HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A3Cleared 510(K)
- K011144LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR3Cleared 510(K)
- K012197POWERHEART CARDIAC RHYTHM MODULE3Cleared 510(K)
- K012428MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR3Cleared 510(K)
- K012030PORTABLE INTENSIVE CARE UNIT3Cleared 510(K)
- K003548PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS3Cleared 510(K)
- K010918LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM3Cleared 510(K)
- K010207PORTABLE INSTENSIVE CARE UNIT3Cleared 510(K)
- K010634HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B3Cleared 510(K)
- K003819HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A3Cleared 510(K)
- K010257ZOLL M SERIES3Cleared 510(K)
- K010214FIRSTSAVE BIPHASIC MODEL #9200 AND 92103Cleared 510(K)
- K002079MULTI-FUNCTION DEFIBRILLATION ELECTRODE3Cleared 510(K)
- K002280PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 26023Cleared 510(K)
- K002445LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES3Cleared 510(K)
- K003565HEARTSTREAM FR2 AED, MODEL M3860A,M3861A3Cleared 510(K)
- K003228K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A3Cleared 510(K)
- K002232AEDEFIBRILLATOR3Cleared 510(K)
- K002806K-DEFIB/PACE, MODEL KDP-60A3Cleared 510(K)
- K000638RESPONDER 30003Cleared 510(K)
- K001725HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A3Cleared 510(K)
- K992543HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE3Cleared 510(K)
- K993036ZOLL M SERIES ETCO2 OPTION3Cleared 510(K)
- K993745K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-803Cleared 510(K)
- K993533POWERHEART AECD3Cleared 510(K)
- K993072SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)3Cleared 510(K)
- K992977HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A3Cleared 510(K)
- K991556ZOLL M SERIES 12SL ANALYSIS OPTION3Cleared 510(K)
- K991910LIFEPAK 12 BIPHASIC3Cleared 510(K)
- K990762ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)3Cleared 510(K)
- K991007K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-603Cleared 510(K)
- K991871HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A3Cleared 510(K)
- K983393LIFEPAK 500 BIPHASIC3Cleared 510(K)
- K984582ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX3Cleared 510(K)
- K982992ZOLL M SERIES SPO2 OPTION3Cleared 510(K)
- K990106ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES3Cleared 510(K)
- K982264FIRSTSAVE BIPHASIC MODELS 9200 AND 92103Cleared 510(K)
- K984286HEARTSTREAM ELECTRODE ADAPTER3Cleared 510(K)
- K981737K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-603Cleared 510(K)
- K981802ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-40033Cleared 510(K)
- K983307MODIFICATION TO PORTABLE INTENSIVE CARE UNIT3Cleared 510(K)
- K983287MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE3Cleared 510(K)
- K982025HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR3Cleared 510(K)
- K982710AECD ARRHYTHMIA DETECTION SOFTWARE3Cleared 510(K)
- K965117LIFE SUPPORT FOR TRAUMA AND TRANSPORT3Cleared 510(K)
- K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE3Cleared 510(K)
- K972241ZOLL REVIVER3Cleared 510(K)
- K973486LIFE PAK 123Cleared 510(K)
- K962359LIFEPAK 3003Cleared 510(K)
- K970741POWERHEART AECD3Cleared 510(K)
- K972418HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)3Cleared 510(K)
- K972970MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE3Cleared 510(K)
- K955890FIRST MEDIC PULSE OXIMETRY MODULE3Cleared 510(K)
- K971149SVL-9130 DEFIBRILLATION ELECTRODE3Cleared 510(K)
- K971148700-SP SERIES DISPOSABLE STIMULATION ELECTRODES3Cleared 510(K)
- K970719700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES3Cleared 510(K)
- K970391QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES3Cleared 510(K)
- K964991700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES3Cleared 510(K)
- K955854LIFEPAK 5003Cleared 510(K)
- K955882MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS3Cleared 510(K)
- K955923MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL3Cleared 510(K)
- K955628FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS3Cleared 510(K)
- K955828MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORS3Cleared 510(K)
- K960329DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD3Cleared 510(K)
- K954957CODEMASTER XL + XL W/SHOCK ADVISORY OPTION3Cleared 510(K)
- K953204PEDIATRIC QUIK-COMBO3Cleared 510(K)
- K954609HEARTSTART 9113Cleared 510(K)
- K954504K-DEFIB/PACE PEDIATRIC ELECTRODE3Cleared 510(K)
- K952101MARQUETTE DEFIB ELECTRODES3Cleared 510(K)
- K941262MARQUETTE DEFIB ELECTRODE3Cleared 510(K)
- K942344ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR3Cleared 510(K)
- K942850ZOLL POWERBASE(TM)3Cleared 510(K)
- K940445VIVALINK AED DEFIBRILLATOR3Cleared 510(K)
- K934692K-DEFIB/PACE PEDIATRIC ELECTRODE3Cleared 510(K)
- K943698STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES3Cleared 510(K)
- K935922360 SLX ADVISORY DEFIBRILLATOR3Cleared 510(K)
- K941970FAST-PATCH3Cleared 510(K)
- K925936LIFEPAK 300 AUTOMATIC ADVISORY DEFRILLATOR3Cleared 510(K)
- K932028PD-1400 PACER/DEFIBRILLATOR3Cleared 510(K)
- K932931D1400 DEFIBRILLATOR W/ DEFIBRILLATION ADVISORY OPT3Cleared 510(K)
- K926172SERIES 1500 DEFIBRILLATOR, MODIFICATION3Cleared 510(K)
- K896919HEARTSTART 30003Cleared 510(K)
- K892005SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 93Cleared 510(K)
- K892065LIFEPAK 250 DEFIBRILLATOR/MONITOR3Cleared 510(K)
- K882067MARQUETTE 1200 DEFIBRILLATOR3Cleared 510(K)
- K883584FIRST MEDIC MODE 6103Cleared 510(K)
- K883344HEARTSTART 1000S3Cleared 510(K)
- K883341HEARTSTART 10003Cleared 510(K)
- K870622HEART*AID 10003Cleared 510(K)
- K860676HEARTSTART 20003Cleared 510(K)
- K853564LIFEPAK 2003Cleared 510(K)
- 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
OneStep Pediatric CPR Multi-Function Electrode
- Page Type
- Cleared 510(K)
- 510(k) Number
- K150055
- 510(k) Type
- Traditional
- Applicant
- BIO-DETEK, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/2/2015
- Days to Decision
- 110 days
- Submission Type
- Summary