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
- DSMAlarm, Leakage Current, Portable1Product Code
- DPSElectrocardiograph2Product Code
- K252361AccurECG Analysis System (v2.0)2Cleared 510(K)
- K252474Withings BeamO (SCT02)2Cleared 510(K)
- K250569Cardiologs Holter Platform2Cleared 510(K)
- K243252ZBPro Diagnostic2Cleared 510(K)
- K243305Masimo W12Cleared 510(K)
- K241217CloudHRV™ System (100-01-001)2Cleared 510(K)
- K241556Cardiac Workstation (5000); Cardiac Workstation (7000)2Cleared 510(K)
- K240229Masimo W12Cleared 510(K)
- K232161DeepRhythm Platform2Cleared 510(K)
- K233266MEDIBLU ECG SYSTEM2Cleared 510(K)
- K232816Electrocardiograph, model: ECG3012Cleared 510(K)
- K232035Impala2Cleared 510(K)
- K232445CSF-4 (CSF-4)2Cleared 510(K)
- K232823MCG-S (AM1000)2Cleared 510(K)
- K231160Cardio Q50, Cardio Q702Cleared 510(K)
- K230834CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H2Cleared 510(K)
- K232974EKGenius Smart System2Cleared 510(K)
- K232512Masimo W12Cleared 510(K)
- K231150Cardio P12Cleared 510(K)
- K230812Withings Scan Monitor 2.02Cleared 510(K)
- K223670MESI mTablet ECG Diagnostic System, MESI mTablet ECG2Cleared 510(K)
- K222902Electrocardiograph: SE-1200 Pro and SE-1201 Pro2Cleared 510(K)
- K223013AccurECG Analysis System2Cleared 510(K)
- K221260CSF-32Cleared 510(K)
- K221141PageWriter TC35 Cardiograph2Cleared 510(K)
- K220535Cardio102Cleared 510(K)
- K221321MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System2Cleared 510(K)
- K212163Coala Heart Monitor2Cleared 510(K)
- K212278Electrocardiograph2Cleared 510(K)
- K220362LE-12CH2Cleared 510(K)
- K212112Cardiologs Holter Platform2Cleared 510(K)
- K201456Scan Monitor2Cleared 510(K)
- K210140electrocardiograph: SE-12022Cleared 510(K)
- K210560Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph2Cleared 510(K)
- K203786MAC 7 - Resting ECG Analysis System2Cleared 510(K)
- K200884B-Secur HeartKey Software Library2Cleared 510(K)
- K191738PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph2Cleared 510(K)
- K193415physIQ Heart Rhythm and Respiration Module2Cleared 510(K)
- K200036AI-ECG Tracker2Cleared 510(K)
- K183425CARDIOVIT AT-102 G22Cleared 510(K)
- K191692KardioScreen2Cleared 510(K)
- K183322physIQ Heart Rhythm and Respiratory Module2Cleared 510(K)
- K182571CardioFlux with Faraday Analytical Cloud2Cleared 510(K)
- K182093ZOLL ECG Analysis Software2Cleared 510(K)
- K183369COR12 ECG2Cleared 510(K)
- K182790Cardio-TriTest v6.52Cleared 510(K)
- K181998CardioBand ECG Event Recorder2Cleared 510(K)
- K173830MAC VU360 Resting ECG Analysis System2Cleared 510(K)
- K173952Universal SmartECG2Cleared 510(K)
- K180234physiQ Heart Rhythm Module2Cleared 510(K)
- K172778CheckMyHeart Plus2Cleared 510(K)
- K172068Kenz Cardico12112Cleared 510(K)
- K173226CardiMax Electrocardiograph2Cleared 510(K)
- K180242HeRO Symphony, HeRO ES, HeRO solo/duet2Cleared 510(K)
- K162665MiCor A100 Wearable ECG Recorder2Cleared 510(K)
- K171942Electrocardiograph2Cleared 510(K)
- K171360CONTEC™ Electrocardiograph2Cleared 510(K)
- K171517Digital Electrocardiograph2Cleared 510(K)
- K163607ECG Acquisition Systems2Cleared 510(K)
- K170154Creavo Vitalscan Magnetocardiograph2Cleared 510(K)
- K171943Electrocardiograph2Cleared 510(K)
- K170182CARDIOVIT FT-12Cleared 510(K)
- K170568CardioLogs ECG Analysis Platform2Cleared 510(K)
- K170995Electrocardiograph2Cleared 510(K)
- K170954Portable ECG Monitor2Cleared 510(K)
- K160667Anybattery C2 Rechargeable Battery2Cleared 510(K)
- K160876PC ECG2Cleared 510(K)
- K160746CARDIOLINE touchECG2Cleared 510(K)
- K160840ECG100+, ECG200+2Cleared 510(K)
- K152135Quantitative Electrocardiographic Detector (QED 2000)2Cleared 510(K)
- K161302PC ECG2Cleared 510(K)
- K152863Portable ECG Monitor2Cleared 510(K)
- K152043Diagnostic Station DS202Cleared 510(K)
- K151135MODEL 621/624 BIOMAGNETOMETER2Cleared 510(K)
- K142969ANI Monitor2Cleared 510(K)
- K160092Digital Electrocardiograph2Cleared 510(K)
- K152427PC ECG2Cleared 510(K)
- K152944Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems2Cleared 510(K)
- K152384Digital Electrocardiograph2Cleared 510(K)
- K150564Spaulding Electrocardiograph 2100iQ2Cleared 510(K)
- K143432Cardio-TriTest2Cleared 510(K)
- K143436InvisionECG System2Cleared 510(K)
- K142551QANS (Quantitative Autonomic Nervous System) Monitoring System2Cleared 510(K)
- K142693ZywieAI Software Library2Cleared 510(K)
- K141946DIGITAL ELECTROCARDIOGRAPH2Cleared 510(K)
- K133985DIGITAL ELECTROCARDIOGRAPH2Cleared 510(K)
- K142288MAC 800 Resting ECG Analysis System2Cleared 510(K)
- K140020HYPERQ ACS-100 SYSTEM2Cleared 510(K)
- K142105ELI 380 ELECTROCARDIOGRAPH2Cleared 510(K)
- K141582CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION2Cleared 510(K)
- K131858DIGITAL ELECTROCARDIOGRAPH2Cleared 510(K)
- K131900CONTEC ELECTROCARDIOGRAPH2Cleared 510(K)
- K131503SE-601 SERIES ELECTROCARDIOGRAPH2Cleared 510(K)
- K122632GUAVA II2Cleared 510(K)
- K130921ALIVECOR HEART MONITOR OTC2Cleared 510(K)
- K132758DIGITAL ELECTROCARDIOGRAPH2Cleared 510(K)
- K133622MAC 2000 ECG ANALYSIS SYSTEM2Cleared 510(K)
- K131819PC ECG2Cleared 510(K)
- K131262DIGITAL ELECTROCARDIOGRAPHS2Cleared 510(K)
- K132068PHILIPS DXL 12/16-LEAD ECG ALGORITHM2Cleared 510(K)
- K130409ALIVECOR HEART MONITOR2Cleared 510(K)
- K130207SPACELABS HEALTHCARE CARDIOEXPRESS2Cleared 510(K)
- K131572MICRO AMBULATORY ECG RECORDER2Cleared 510(K)
- K131573CP150 ELECTROCARDIOGRAPH2Cleared 510(K)
- K121825CS-MAG II2Cleared 510(K)
- K123816DIGITAL ELECTROCARDIOGRAPHS2Cleared 510(K)
- K123217CARDEASCREEN2Cleared 510(K)
- K120770QT GUARD PLUS ANALYSIS SYSTEM2Cleared 510(K)
- K122356ALIVECOR HEART MONITOR FOR IPHONE2Cleared 510(K)
- K122712DIGITAL ELECTROCARDIOGRAPH2Cleared 510(K)
- K122073ELI 280 ELECTROCARDIOGRAPH2Cleared 510(K)
- K120865RSCRIBE ELECTROCARDIOGRAPH2Cleared 510(K)
- K112622HANDHELD ECG MONITOR2Cleared 510(K)
- K113306CARDIO 72Cleared 510(K)
- K121009HEARTCHECK ECG PEN WITH GEMS HOME2Cleared 510(K)
- K113485ELECTROCARDIOGRAPH2Cleared 510(K)
- K113144PAGEWRITER TC 20, 30, 50, 702Cleared 510(K)
- K120188ELECTROCARDIOGRAPH2Cleared 510(K)
- K112959CALG-STR EXERCISE ECG ANALYSIS ALGORITHM2Cleared 510(K)
- K111159HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME2Cleared 510(K)
- K113234MOBCARDIO SYSTEM2Cleared 510(K)
- K102378VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI2Cleared 510(K)
- K103791PHYSIOGLOVE ES WITH ECG ANALYSIS2Cleared 510(K)
- K112431DIGITAL ELECTROCARDIOGRAPH2Cleared 510(K)
- K111438REKA E1002Cleared 510(K)
- K111805ECG SERIES ELECTROCARDIOGRAPH2Cleared 510(K)
- K112135ECG-6 SERIES ELECTROCARDIOGRAPH2Cleared 510(K)
- K110328ACG-8511 PORTABLE ECG MONITOR2Cleared 510(K)
- K103077ECG PEN2Cleared 510(K)
- K111601HERO2Cleared 510(K)
- K102767CARDIO XP2Cleared 510(K)
- K103765MAC 600 RESTING ECG ANALYSIS SYSTEM2Cleared 510(K)
- K110266MAC 5500 HD, MAC 35002Cleared 510(K)
- K101867VICOR PD2I ANALYZER2Cleared 510(K)
- K103427MOBILEECG SYSTEM2Cleared 510(K)
- K103640MIDMARK IQECG2Cleared 510(K)
- K110065SPAULDING IQ ELECTROCARDIOGRAPH2Cleared 510(K)
- K101876DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-60102Cleared 510(K)
- K101569V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER2Cleared 510(K)
- K102206ELI 10 ELECTROCARDIOGRAPH MODEL ELI 102Cleared 510(K)
- K101016ANS SYSTEM2Cleared 510(K)
- K102854PC ECG2Cleared 510(K)
- K102830ELECTROCARDIOGRAPH2Cleared 510(K)
- K100813QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB2Cleared 510(K)
- K101403ELI 250 ELECTROCARDIOGRAPH2Cleared 510(K)
- K101115ELI 150 ELECTROCARDIOGRAPH MODEL ELI 1502Cleared 510(K)
- K093211CARECENTER MD2Cleared 510(K)
- K100127ELI 230 ELECTROCARDIOGRAPH2Cleared 510(K)
- K093869SE-601 SERIES ELECTROCARDIOGRAPH2Cleared 510(K)
- K093872HANDHELD ECG MONITOR, MODEL MD1002Cleared 510(K)
- K093339ELI PC ELECTROCARDIOGRAPH2Cleared 510(K)
- K093172QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)2Cleared 510(K)
- K092663ELI 350 ELECTROCARDIOGRAPH2Cleared 510(K)
- K092010PC ECG, MODEL SE-10102Cleared 510(K)
- K083715BELTBEAT WF-4002Cleared 510(K)
- K092576GEM HEART ONE/ONE+2Cleared 510(K)
- K090936SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A2Cleared 510(K)
- K091513SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-12002Cleared 510(K)
- K091397ECSCOPE 2002Cleared 510(K)
- K090367SE-601 SERIES ELECTROCARDIOGRAPH2Cleared 510(K)
- K091358ECSCOPE 1002Cleared 510(K)
- K090249MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM2Cleared 510(K)
- K082967MORTARA STRESS ECHO BED2Cleared 510(K)
- K090483SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS2Cleared 510(K)
- K090212MAC 800 RESTING ECG ANALYSIS SYSTEM2Cleared 510(K)
- K082124CARDITTE MICROTEL2Cleared 510(K)
- K082946MORTARA ELI 350 ELECTROCARDIOGRAPH2Cleared 510(K)
- K082709VICOR PD2I ANALYZER, VERSION 2.12Cleared 510(K)
- K082380VICARDIO 12B2Cleared 510(K)
- K082013CLUE MEDICAL AND CLUE MEDICAL BASIC2Cleared 510(K)
- K080933HANDHELD ECG MONITOR, MODEL MD1002Cleared 510(K)
- K082312PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)2Cleared 510(K)
- K082173Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S2Cleared 510(K)
- K081437MAC 1600 ECG ANALYSIS SYSTEM2Cleared 510(K)
- K081473HERO, VERSION 2.02Cleared 510(K)
- K080999PAGEWRITER CARDIOGRAPH2Cleared 510(K)
- K080884QHRV 1 - HEALTH ASSESSMENT SYSTEM2Cleared 510(K)
- K073625MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM2Cleared 510(K)
- K080036PORTABLE ECSCOPE 12I2Cleared 510(K)
- K072449CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS2Cleared 510(K)
- K071168THE PORTABLE ANSISCOPE2Cleared 510(K)
- K072353PORTABLE ECSCOPE2Cleared 510(K)
- K072217ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M2Cleared 510(K)
- K072060QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V2Cleared 510(K)
- K061123PALM ECG RECORDER, MODEL EP-201/2022Cleared 510(K)
- K070614CORSCREEN2Cleared 510(K)
- K070136AUDICOR 200 SYSTEM, MODELS 200D AND 200S2Cleared 510(K)
- K062282MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.02Cleared 510(K)
- K070539MORTARA ELI 10 ELECTROCARDIOGRAPH2Cleared 510(K)
- K062894INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.02Cleared 510(K)
- K062677ELI 350 ELECTROCARDIOGRAPH2Cleared 510(K)
- K062469VOYAGER 122Cleared 510(K)
- K062068INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.02Cleared 510(K)
- K060766PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-8012Cleared 510(K)
- K052511CARDIOFAX CE, MODEL ECG-1500 A2Cleared 510(K)
- K050674PHYSIOGLOVE ES2Cleared 510(K)
- K060167ATRIA 3100, ATRIA 61002Cleared 510(K)
- K052898IQMARK EZ STRESS2Cleared 510(K)
- K051163GALIX ECG PROFESSIONAL STATION2Cleared 510(K)
- K052295CARDIOSOFT PC ECG, USB VERSION2Cleared 510(K)
- K052303READMYHEART, MODEL RMH2.02Cleared 510(K)
- K053083DATRIX CARDIO WIFI ELECTROCARDIOGRAPH2Cleared 510(K)
- K051534CARDIOLINE AR 600, AR 1200, AR 21002Cleared 510(K)
- K052049PHILIPS 12-LEAD ALGORITHM2Cleared 510(K)
- K050620READMYHEART, MODEL RMH3.02Cleared 510(K)
- K050858ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM2Cleared 510(K)
- K051126CARDIOSCOPE SONOPLUS 30002Cleared 510(K)
- K050686CARDIOVIT AT-10PLUS2Cleared 510(K)
- K043380MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 12Cleared 510(K)
- K05007412-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP2002Cleared 510(K)
- K043074LIBERTY SYSTEM2Cleared 510(K)
- K042827CARDIOFAX CE, MODEL PEA-1110K2Cleared 510(K)
- K042814READMYHEART2Cleared 510(K)
- K042177MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM2Cleared 510(K)
- K033488CMI MAGNETOCARDIOGRAPH2Cleared 510(K)
- K031557CARDIOVIT AT-1022Cleared 510(K)
- K040313HRV TOOLS2Cleared 510(K)
- K032145AUDICOR UPGRADE SYSTEM2Cleared 510(K)
- K032200ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH2Cleared 510(K)
- K024283CARDIODIRECT, MODELS 12M, 12I, 12S2Cleared 510(K)
- K031182ELI 200+ AUDICOR2Cleared 510(K)
- K031422PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 8602912Cleared 510(K)
- K030535EKGCARD SYSTEM2Cleared 510(K)
- K030104PRIME ECG SYSTEM2Cleared 510(K)
- K024278PACEART SYSTEM2Cleared 510(K)
- K021230HERO2Cleared 510(K)
- K022618X-SCRIBE II2Cleared 510(K)
- K022149CARDIAC DIAGNOSTIC SYSTEM, MODEL CH20002Cleared 510(K)
- K022152HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS2Cleared 510(K)
- K013615MICRO-INDUCTION 1000 SYSTEM2Cleared 510(K)
- K021171Q-STRESS ECHO BED2Cleared 510(K)
- K020366GLOBAL ECG MANAGEMENT SYSTEM (GEMS)2Cleared 510(K)
- K020708PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES2Cleared 510(K)
- K014262COSMED QUARK C12/QUARK T122Cleared 510(K)
- K012414PRIME ECG SYSTEM2Cleared 510(K)
- K013717BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY2Cleared 510(K)
- K013367CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH2Cleared 510(K)
- K012686CAIRD TECHNOLOGY HOLTER 20002Cleared 510(K)
- K013565CARDIAC DIAGNOSTIC SYSTEM, MODEL CH20002Cleared 510(K)
- K013564MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS2Cleared 510(K)
- K012264MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC2Cleared 510(K)
- K012263MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N30242Cleared 510(K)
- K012540BLY-501 ADAPTOR2Cleared 510(K)
- K011436MOBILE-PATIENT VIEWER2Cleared 510(K)
- K011177BCI ADVISOR VITAL SIGNS MONITOR (9200)2Cleared 510(K)
- K010955BMT ANSCORE HEALTH MANAGEMENT SYSTEM2Cleared 510(K)
- K010822AB CARDIETTE START 200 HV2Cleared 510(K)
- K010758HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS2Cleared 510(K)
- K010505TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY2Cleared 510(K)
- K002822VERTEX SYSTEM2Cleared 510(K)
- K003392CARDIO MONITOR CENTER VISION; MODEL S-CV7-002Cleared 510(K)
- K001896KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC2Cleared 510(K)
- K002197CARTOUCH2Cleared 510(K)
- K002473WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES2Cleared 510(K)
- K002459PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH2Cleared 510(K)
- K002074AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES2Cleared 510(K)
- K993875BMT ANSCORE HEALTH MANAGEMENT SYSTEM2Cleared 510(K)
- K001492QUINTON Q-STRESS, MODEL 0004832Cleared 510(K)
- K001034MODEL APS ALTERNANS PROCESSING SYSTEM2Cleared 510(K)
- K000645GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.112Cleared 510(K)
- K993414PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.22Cleared 510(K)
- K991786MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION2Cleared 510(K)
- K991831BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.12Cleared 510(K)
- K972991MONITOR ONE NDX2Cleared 510(K)
- K981697CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM2Cleared 510(K)
- K974220MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE2Cleared 510(K)
- K981807CARDIOVISION SOFTWARE, MODEL S-CV5-962Cleared 510(K)
- K973426ANS 2000 ECG MONITOR AND RESPIRATION PACER2Cleared 510(K)
- K961798CT 200 ELECTROCARDIOGRAPH2Cleared 510(K)
- K981951CT 100 ELECTROCARDIOGRAPH2Cleared 510(K)
- K980362MRI COMPATIBLE MONITOR AND ACCESSORIES2Cleared 510(K)
- K972996EASY ECG PC BASED ELECTROCARDIOGRAPH2Cleared 510(K)
- K974351BIOLOG 3000 ELECTROCARDIOGRAPH2Cleared 510(K)
- K974746M1765A ECG MANAGER2Cleared 510(K)
- K972603ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B2Cleared 510(K)
- K974079FORMULA FOR ARCHIMED2Cleared 510(K)
- K973437HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES2Cleared 510(K)
- K972746ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/1002Cleared 510(K)
- K972199SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS2Cleared 510(K)
- K971038KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE2Cleared 510(K)
- K972310NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH2Cleared 510(K)
- K964784SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)2Cleared 510(K)
- K964408POSEIDON CARDIAC MONITORING SYSTEM (PCMS)2Cleared 510(K)
- K963578PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)2Cleared 510(K)
- K970787ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)2Cleared 510(K)
- K963198PS-41 6M PATIENT SIMULATOR2Cleared 510(K)
- K963400NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER2Cleared 510(K)
- K961247AS/3 LIGHT MONITOR2Cleared 510(K)
- K961401HP CATHSTATION - MODEL M1264B2Cleared 510(K)
- K955891CARDIOVIEW TRANSTELEPHONIC SOFTWARE2Cleared 510(K)
- K951128MEDILOG STRESSLINK2Cleared 510(K)
- K960321CARDIOCATH CATHETERIZATION LAB SYSTEM2Cleared 510(K)
- K955546PATIENT MONITOR MODEL 405P2Cleared 510(K)
- K955113DINAMAP SELECT MULTI-PARAMETER SYSTEM2Cleared 510(K)
- K955416CARDIMAX MODEL FX-21112Cleared 510(K)
- K955045OMNI-TRAK PATIENT MONITORING SYSTEM2Cleared 510(K)
- K955642NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER2Cleared 510(K)
- K960449PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)2Cleared 510(K)
- K950989CARDIOSMART2Cleared 510(K)
- K950018CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM2Cleared 510(K)
- K954066MINISCOPE MS-32Cleared 510(K)
- K950004HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER2Cleared 510(K)
- K9534156200 VITAL SIGNS MONITOR2Cleared 510(K)
- K952173HEWLETT-PACKARD MODEL M1264B CATHSTATION2Cleared 510(K)
- K945626QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH2Cleared 510(K)
- K943709DINAMAP PLUS VITAL SIGNS MONOITOR2Cleared 510(K)
- K950779HEART RATE VARIABILITY SOFTWARE OPTION2Cleared 510(K)
- K946205CARDIOVIT AT-1, P-802Cleared 510(K)
- K933156DATEX AS/3 PATIENT MONITOR2Cleared 510(K)
- K935394MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION2Cleared 510(K)
- K942629NCE REPLACEMENT BATTERIES2Cleared 510(K)
- K941811HP M1175A, M1176A, COMPONENT MONITORING SYSTEM2Cleared 510(K)
- K934439RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR2Cleared 510(K)
- K933065BATTERY PACK# S1009LA2Cleared 510(K)
- K933404CRITIKON CENTRAL STATIN MONITOR2Cleared 510(K)
- K923406BIOSCOPE2Cleared 510(K)
- K924544CARDIAX2Cleared 510(K)
- K921930SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI2Cleared 510(K)
- K930558MORTARA INSTRUMENT, INC. E-SCRIBE2Cleared 510(K)
- K922703THE ACTA FORMULA2Cleared 510(K)
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- K852322VSM-52Cleared 510(K)
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- K852770CARIOLINE(ELECTROCARDIOGRAPH)2Cleared 510(K)
- K851633CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL2Cleared 510(K)
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- K840869SURGICAL MODULE 7000 ECG2Cleared 510(K)
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- K841611QUINTON 901 & 900 HOLTER SCANNER2Cleared 510(K)
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- K832888ECG INTERFERENCE FILTER TF-032Cleared 510(K)
- K832421BATTERY-OPERATED ELECTROCARDIOGRAPH2Cleared 510(K)
- K832050MORTARA INSTRUMENT #1012Cleared 510(K)
- K832883MINI-PECG2Cleared 510(K)
- K832227G-20002Cleared 510(K)
- K833458CASE-II2Cleared 510(K)
- K833470PACEMAKER EVALUATION MODULE-3302Cleared 510(K)
- K832184SIMPLISCRIPTOR EK 31/101 037 162Cleared 510(K)
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- K832013LME PATIENT MONITOR SMS 1512Cleared 510(K)
- K832014MULTISCRIPTOR EK #403 VARIOUS MODEL2Cleared 510(K)
- K832212PATIENT SELECTOR FUNCTION BLOCK2Cleared 510(K)
- K831429AS 191 ECG TELEMETRY MODULE2Cleared 510(K)
- K831878CARDIO-SCOPE MINI MONITOR2Cleared 510(K)
- K830666APNEA/BRADYCARDIA MONITOR HB 952Cleared 510(K)
- K830791UNIVERSAL MEDDARS SYSTEM2Cleared 510(K)
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- K823281MODEL RM 6000, 6100,6200 POLYGRAPH2Cleared 510(K)
- K823529FULL-DISCLOSURE AMBULATORY ECG SYSTEM2Cleared 510(K)
- K823220COSMOS2Cleared 510(K)
- K822768ELECTROCARDIOGRAPH (74 DPS) #YM-1022Cleared 510(K)
- K822582QUIKPAGE SCANNER2Cleared 510(K)
- K821758QUINTON Q, SCAN MODELS 900 & 9012Cleared 510(K)
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- K821090CARDI-O-LIFE MODEL 88232Cleared 510(K)
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- K813021FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-362Cleared 510(K)
- K813022FUKUDA DENSHI CARDIMAX FK-122Cleared 510(K)
- K811949KENL-ECG-32Cleared 510(K)
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- K811121CENTRAL STATION MONITORING SYSTEMS2Cleared 510(K)
- K811016CC-1002Cleared 510(K)
- K810988IBM 5885 DIGITAL ECG ACQUISITION CART2Cleared 510(K)
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- K810154LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM2Cleared 510(K)
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- K802368OPTION 301 PACEMAKER EVAL. MODULE MAC-12Cleared 510(K)
- K810176ECG FUNCTION BLOCK2Cleared 510(K)
- K810263MICROPROCESSOR CONTROLLED ELECTROCARDIO2Cleared 510(K)
- K810104ECG ARRHYTHMIA STIMULATOR2Cleared 510(K)
- K802113SIRECUST 400 SYSTEM PATIENT MONITORING2Cleared 510(K)
- K803309VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH2Cleared 510(K)
- K802952MODEL HEC-7 HEART EVALUATION COMPUTER2Cleared 510(K)
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- K800659SCHILLER MSG-12Cleared 510(K)
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- K800593SIRECUST 311S2Cleared 510(K)
- K800492VSM-1 PHYSIOLOGICAL MONITOR2Cleared 510(K)
- K800004ECG MONITOR OSCILLOSCOPE MODEL OEC-32002Cleared 510(K)
- K800005ECG MONITOR OSCILLOSCOPE MODEL OEC-31002Cleared 510(K)
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- K792072MODEL 685/686 DYNAMIC ELECTROCARDI0-2Cleared 510(K)
- K791795COMP-ACT IV2Cleared 510(K)
- K791201SCINTISTRESS SYSTEM2Cleared 510(K)
- K791540ELECTROCARDIOGRAPH MODEL ECG-54032Cleared 510(K)
- K791421MINISCOPE MS-2B ELECTROCARDIOSCOPE2Cleared 510(K)
- K791420MINIGRAPH MG-I ELECTROCARDIOGRAPH2Cleared 510(K)
- K791364QUINTON MODEL 630 AND 636 ECG DATA CART2Cleared 510(K)
- K791151ECG CHANNEL OF DIAGNOSTIC SYSTEM2Cleared 510(K)
- K790939MODEL 78501A PATIENT MONITORING SYSTEM2Cleared 510(K)
- K790794SIEMENS CARDIOSTAT 7012Cleared 510(K)
- K790869CARDIO-SLIDECOMP2Cleared 510(K)
- K790739QUINTON MODEL 530X ECG DATA CART2Cleared 510(K)
- K79069125-50 EKG RULER2Cleared 510(K)
- K790300META III2Cleared 510(K)
- K790233ELECTROCARDIOGRAPH, AT-300 3 CHANNEL2Cleared 510(K)
- K790114ELECTROCARDIOGRAPH, EK-92Cleared 510(K)
- K781679MONITOR/MINI SCOPE2Cleared 510(K)
- K781054LIFELINE AMBULATORY2Cleared 510(K)
- K780307CARDIAC MINIGRAPH2Cleared 510(K)
- K780166STRESS TEST SYSTEM2Cleared 510(K)
- K780138EK-6702Cleared 510(K)
- K771380ELAPSED TIME INDICATOR MODEL 21361A2Cleared 510(K)
- K770832PORTASCOPE II2Cleared 510(K)
- K770760MONITOR, PORTABLE, PATIENT, G.E.2Cleared 510(K)
- K770366ISOLATED ELECTROCARDIOGRAPH MODEL 12072Cleared 510(K)
- K761023SIMULATOR, 10 LEAD ECG2Cleared 510(K)
- K770037ELECTROCARDIOGRAPH MODEL 3442Cleared 510(K)
- K761198MODEL 3044 3-CHANNEL STRESS TEST SYSTEM2Cleared 510(K)
- K761014CARDIART 108T/3132Cleared 510(K)
- K760271ELECTROCARDIOGRAPH, EK-7 (3-CHANNELS)2Cleared 510(K)
- K760854THREE-CHANNEL STRESS TEST SYSTEM (M633)2Cleared 510(K)
- K760268ELECTROCARDIOGRAPH EK-6 W/OPTIONAL CIRC.2Cleared 510(K)
- K760272CIRCUIT, PRINTED, SERVO-MECHANISM2Cleared 510(K)
- K760926ELECTROCARDIOGRAPH (MODEL VS-4B)2Cleared 510(K)
- K760266MONITOR, ELECTROCARDIOSCOPE2Cleared 510(K)
- K760677LIFEPAK 5 CARDIOSCOPE MODULE (NPN 5)2Cleared 510(K)
- K760612SPACELABS SERIES 10002Cleared 510(K)
- K760542ELECTROCARDIOGRAPH (#1505A)2Cleared 510(K)
- K760510MONITORING SYSTEM, REHABILITATION2Cleared 510(K)
- K760463STRESS SYSTEM, SINGLE-CHANNEL (#21125)2Cleared 510(K)
- K760465STRESS SYSTEM, 3-CHANNEL (#21127A)2Cleared 510(K)
- K760265ELCTROCARDIOGRAPH, EK-62Cleared 510(K)
- K760150MONITOR, PATIENT (MODEL 78331A)2Cleared 510(K)
- DPTProbe, Blood-Flow, Extravascular2Product Code
- DPWFlowmeter, Blood, Cardiovascular2Product Code
- DQBPhlebograph, Impedance2Product Code
- DQCPhonocardiograph1Product Code
- DQHCardiograph, Apex (Vibrocardiograph)2Product Code
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency2Product Code
- DRIMonitor, Line Isolation1Product Code
- DRJSystem, Signal Isolation1Product Code
- DRQAmplifier And Signal Conditioner, Transducer Signal2Product Code
- DRRAmplifier And Signal Conditioner, Biopotential2Product Code
- DRSTransducer, Blood-Pressure, Extravascular2Product Code
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)2Product Code
- DRWAdaptor, Lead Switching, Electrocardiograph2Product Code
- DRXElectrode, Electrocardiograph2Product Code
- DRZOscillometer2Product Code
- DSACable, Transducer And Electrode, Patient, (Including Connector)2Product Code
- DSBPlethysmograph, Impedance2Product Code
- DSFRecorder, Paper Chart1Product Code
- DSHRecorder, Magnetic Tape, Medical2Product Code
- DXHTransmitters And Receivers, Electrocardiograph, Telephone2Product Code
- DXJDisplay, Cathode-Ray Tube, Medical2Product Code
- DXKEchocardiograph2Product Code
- DXOTransducer, Pressure, Catheter Tip2Product Code
- DXPTransducer, Vessel Occlusion2Product Code
- DXRBallistocardiograph2Product Code
- DYCVectorcardiograph2Product Code
- JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic2Product Code
- JONTransducer, Apex Cardiographic2Product Code
- JOOTransducer, Heart Sound2Product Code
- JOPTransducer, Ultrasonic2Product Code
- KRCTester, Electrode, Surface, Electrocardiographic2Product Code
- MLCMonitor, St Segment2Product Code
- MLNElectrode, Electrocardiograph, Multi-Function2Product Code
- MLOElectrocardiograph, Ambulatory, With Analysis Algorithm2Product Code
- MSXSystem, Network And Communication, Physiological Monitors2Product Code
- MUDOximeter, Tissue Saturation2Product Code
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2Product Code
- MWJElectrocardiograph, Ambulatory (Without Analysis)2Product Code
- MXCRecorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)2Product Code
- NMDOximeter, Tissue Saturation, Reprocessed2Product Code
- NQHSensor, Pressure, Aneurysm, Implantable2Product Code
- OCHOximeter, Infrared, Sporting, Aviation2Product Code
- OEYSingle Lead Over-The-Counter Electrocardiograph2Product Code
- QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate2Product Code
- OFILaser Blood Flow Kit2Product Code
- PFYLow Patient Acuity Monitoring System2Product Code
- PLBMultivariate Vital Signs Index2Product Code
- PPWAdjunctive Cardiovascular Status Indicator2Product Code
- QAQAdjunctive Predictive Cardiovascular Indicator2Product Code
- QDAElectrocardiograph Software For Over-The-Counter Use2Product Code
- QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use2Product Code
- QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator2Product Code
- QNVAdjunctive Hemodynamic Indicator With Decision Point2Product Code
- QOKHardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate2Product Code
- QUOAdjunctive Heart Failure Status Indicator2Product Code
- QXZAdjunctive Epicardial Vascular Physiologic Status Indicator2Product Code
- SARAdjunctive Hemodynamic Indicator With Decision Point For Military Use2Product Code
- SDJAdjunctive Cardiac Amyloidosis Status Indicator2Product Code
- SDYLoss Of Pulse Notification Software2Product Code
- 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
- Subpart F—Therapeutic DevicesCFR Sub-Part
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MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K013564
- 510(k) Type
- Special
- Applicant
- Cambridge Heart, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/21/2001
- Days to Decision
- 26 days
- Submission Type
- Summary