Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- DQDStethoscope, Electronic2Product Code
- DQECatheter, Oximeter, Fiber-Optic2Product Code
- DQGMicrosphere, Trace3Product Code
- DQKComputer, Diagnostic, Programmable2Product Code
- DQOCatheter, Intravascular, Diagnostic2Product Code
- DQPKit, Balloon Repair, Catheter3Product Code
- DQRCannula, Catheter2Product Code
- DQTOccluder, Catheter Tip2Product Code
- DQXWire, Guide, Catheter2Product Code
- DQYCatheter, Percutaneous2Product Code
- DRACatheter, Steerable2Product Code
- DRBStylet, Catheter2Product Code
- DRCTrocar2Product Code
- DREDilator, Vessel, For Percutaneous Catheterization2Product Code
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2Product Code
- DSIDetector And Alarm, Arrhythmia2Product Code
- K240177Zio AT® device (A100A1001)2Cleared 510(K)
- K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System2Cleared 510(K)
- K231276SmartCardia 7L Platform2Cleared 510(K)
- K193104Unified Arrhythmia Diagnostic System PocketECG IV2Cleared 510(K)
- K192732BodyGuardian Remote Monitoring System2Cleared 510(K)
- K190574Patient Assistant Model PA970002Cleared 510(K)
- K182532Liba3 System2Cleared 510(K)
- K181658MobileECG 2 BT2Cleared 510(K)
- K173969Medicalgorithmics Unified Cardiac Rehabilitation System2Cleared 510(K)
- K173170Epicardia Anywhere2Cleared 510(K)
- K153473Braemar Telemetry Patch System2Cleared 510(K)
- K153477EMMa Electronic Monitoring Management2Cleared 510(K)
- K152701Matrix Mini ECG Monitor2Cleared 510(K)
- K152305Nihon Kohden Afib Detection Program QP-039P2Cleared 510(K)
- K151835Vital Signs Patch System2Cleared 510(K)
- K151269ECG Mini System Continuous ECG Monitor and Arrhythmia Detector2Cleared 510(K)
- K152491MoMe Software Platform2Cleared 510(K)
- K152550MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM2Cleared 510(K)
- K151188BodyGuardian Remote Monitoring System2Cleared 510(K)
- K143359CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector2Cleared 510(K)
- K151681IntelliVue Patient Monitor2Cleared 510(K)
- K150117Medtronic Patient Asistant2Cleared 510(K)
- K150310IntelliVue Patient Monitor2Cleared 510(K)
- K142352CardiacLinx2Cleared 510(K)
- K141441MENNTOR X72Cleared 510(K)
- K132407VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)2Cleared 510(K)
- K142180TELESENSE2Cleared 510(K)
- K140548CORCAM HEART MONITOR2Cleared 510(K)
- K131000V-PATCH SYSTEM2Cleared 510(K)
- K124060MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM2Cleared 510(K)
- K121197BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT2Cleared 510(K)
- K112921MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM2Cleared 510(K)
- K120774ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT2Cleared 510(K)
- K113125INTELLIVUE MX40 PATIENT MONITOR2Cleared 510(K)
- K111160INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)2Cleared 510(K)
- K102507AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR2Cleared 510(K)
- K103764REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 95282Cleared 510(K)
- K110499CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR2Cleared 510(K)
- K103142SPACELABS MULTI-PARAMETER MODULE2Cleared 510(K)
- K102111MEDICAL MAGNETIC TAPE RECORDER2Cleared 510(K)
- K101703MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-000842Cleared 510(K)
- K101639CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR2Cleared 510(K)
- K093766VITALOGIK 6000/65002Cleared 510(K)
- K100155TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM2Cleared 510(K)
- K092947TELESENTRY, MODEL TS012Cleared 510(K)
- K091927INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP902Cleared 510(K)
- K091971AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM2Cleared 510(K)
- K090037MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG2Cleared 510(K)
- K090834EPICARDIA 50002Cleared 510(K)
- K083287AVIVO MOBILE PATIENT MANAGEMENT SYSTEM2Cleared 510(K)
- K083517INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP902Cleared 510(K)
- K082475REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 95282Cleared 510(K)
- K082633INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP902Cleared 510(K)
- K081444BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM2Cleared 510(K)
- K081257CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR2Cleared 510(K)
- K071889DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE2Cleared 510(K)
- K071995CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR2Cleared 510(K)
- K073140VITALOGIK MODEL 4000/45002Cleared 510(K)
- K071655REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,95382Cleared 510(K)
- K071641REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)2Cleared 510(K)
- K071805NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX2Cleared 510(K)
- K062976MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER2Cleared 510(K)
- K070260STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.02Cleared 510(K)
- K053263CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN10032Cleared 510(K)
- K052288VITALOGIK2Cleared 510(K)
- K052160ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)2Cleared 510(K)
- K050919LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P2Cleared 510(K)
- K050605SPACELABS MEDICAL MULTIPARAMETER MODULE 914962Cleared 510(K)
- K050175SPACELABS MEDICAL MULTIPARAMETER MODULE 914962Cleared 510(K)
- K024213SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 6552Cleared 510(K)
- K033305INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM2Cleared 510(K)
- K032858THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.2Cleared 510(K)
- K031433SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS2Cleared 510(K)
- K032370CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION2Cleared 510(K)
- K023798MODIFICATION TO ENVOY PATIENT MONITOR2Cleared 510(K)
- K020550PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX2Cleared 510(K)
- K022453MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM2Cleared 510(K)
- K013046COSMOS SYSTEM2Cleared 510(K)
- K021376DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE2Cleared 510(K)
- K021097QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.522Cleared 510(K)
- K021300MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B2Cleared 510(K)
- K021251ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.2Cleared 510(K)
- K012467SOLAR 8000M SYSTEM2Cleared 510(K)
- K002604CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM2Cleared 510(K)
- K020084FUKUDA DENSHI DYNASCOPE MODEL DS-57002Cleared 510(K)
- K012241CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN10012Cleared 510(K)
- K014159PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR2Cleared 510(K)
- K012336MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 205002Cleared 510(K)
- K011339QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 142Cleared 510(K)
- K012461SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER2Cleared 510(K)
- K011784MODIFICATION TO ENVOY PATIENT MONITOR2Cleared 510(K)
- K011824AGILENT M2636B TELEMON B MONITOR (TELEMON B)2Cleared 510(K)
- K001120ENVOY PATIENT MONITOR2Cleared 510(K)
- K002758AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A2Cleared 510(K)
- K002068ORG-9200A2Cleared 510(K)
- K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 0005032Cleared 510(K)
- K003246SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION2Cleared 510(K)
- K003179SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM2Cleared 510(K)
- K001359DASH 3000/4000 PATIENT MONITOR2Cleared 510(K)
- K001436AGILENT M2636A TELEMON MONITOR2Cleared 510(K)
- K000779APEXPRO TELEMETRY SYSTEM2Cleared 510(K)
- K001333AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI2Cleared 510(K)
- K001057AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR2Cleared 510(K)
- K000746FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX2Cleared 510(K)
- K000822AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR2Cleared 510(K)
- K993757SOLAR 7/80002Cleared 510(K)
- K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)2Cleared 510(K)
- K993383HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B2Cleared 510(K)
- K993531PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX2Cleared 510(K)
- K993516HP M2600A VIRIDIA TELEMETRY SYSTEM2Cleared 510(K)
- K992637MUSE CARDIOVASCULAR INFORMATION SYSTEM2Cleared 510(K)
- K993171HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A2Cleared 510(K)
- K991773HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P2Cleared 510(K)
- K990093ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW2Cleared 510(K)
- K990972HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T2Cleared 510(K)
- K984089ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW2Cleared 510(K)
- K990125HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K2Cleared 510(K)
- K981376HEWLETT-PACKARD M1205A VIRIDIA 24 CT2Cleared 510(K)
- K983980SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS2Cleared 510(K)
- K980045CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM2Cleared 510(K)
- K983632SIEMENS SC 8000 BEDSIDE MONITOR2Cleared 510(K)
- K980186ZYMED TELEMETRY SYSTEM2Cleared 510(K)
- K980429HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM)2Cleared 510(K)
- K982730SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR2Cleared 510(K)
- K982697MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR2Cleared 510(K)
- K974698SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS2Cleared 510(K)
- K980728FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM2Cleared 510(K)
- K980882SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR2Cleared 510(K)
- K974792CS/3(TM) MONITORS*2Cleared 510(K)
- K972502SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 904962Cleared 510(K)
- K980625SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)2Cleared 510(K)
- K974747CS/3 ARRHYTHMIA WORKSTATION2Cleared 510(K)
- K974510ENVOY PATIENT MONITOR2Cleared 510(K)
- K971910MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)2Cleared 510(K)
- K972498OBSERVER * CENTRAL STATION2Cleared 510(K)
- K970358ENSEMBLE CENTRAL STATION MONITOR2Cleared 510(K)
- K972714SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM2Cleared 510(K)
- K971131FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR2Cleared 510(K)
- K972282SPACELABS MEDICAL PCIS PATIENT MONITORS2Cleared 510(K)
- K960884TELE TRENS TM 102Cleared 510(K)
- K964624SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM2Cleared 510(K)
- K970585FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR2Cleared 510(K)
- K970348SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER2Cleared 510(K)
- K970920SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM2Cleared 510(K)
- K964593DIASCOPE TRAVELLER PLUS (4053)2Cleared 510(K)
- K970012ESCORT LINK CENTRAL STATION MONITOR2Cleared 510(K)
- K965062SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES2Cleared 510(K)
- K964832HEWLETT-PACKARD CENTRALVUE SOFTWARE2Cleared 510(K)
- K970545DASH 1000 PATIENT MONITOR2Cleared 510(K)
- K964187FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR2Cleared 510(K)
- K952912SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE2Cleared 510(K)
- K962970SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION2Cleared 510(K)
- K963057FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER2Cleared 510(K)
- K962827ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)2Cleared 510(K)
- K962291SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM2Cleared 510(K)
- K955023BRENTWOOD PC-ECG2Cleared 510(K)
- K962404SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM2Cleared 510(K)
- K964122HP STAR ST AND ARRHHYTHMIA SOFTWARE2Cleared 510(K)
- K961165HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A2Cleared 510(K)
- K960418EAGLE PATIENT MONITOR2Cleared 510(K)
- K961139EAGLE PATIENT MONITOR MODEL 3000/31002Cleared 510(K)
- K955743SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM2Cleared 510(K)
- K955059OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER2Cleared 510(K)
- K952054SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960)2Cleared 510(K)
- K954852SOLAR 9000 ANESTHESIA INFORMATION MONITOR2Cleared 510(K)
- K952417QUEST EXERCISE STRESS SYSTEM2Cleared 510(K)
- K935732CARDIO PERFECT ST 20012Cleared 510(K)
- K945944NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM2Cleared 510(K)
- K951370ZYMED TELEMETRY SYSTEM; MODEL T80102Cleared 510(K)
- K9513711481 T DIGITAL TELEMETRY SYSTEM WITH S-T SEGMENT ANALYSIS OPTION2Cleared 510(K)
- K950821HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 242Cleared 510(K)
- K952885SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER2Cleared 510(K)
- K945429SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352)2Cleared 510(K)
- K9421963050 DIASCOPE NT PATIENT MONITOR2Cleared 510(K)
- K946306SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM2Cleared 510(K)
- K934913HEARTRAC ECG MONITORING SYSTEM2Cleared 510(K)
- K944422BSM-8800A BEDSIDE MONITOR2Cleared 510(K)
- K935877NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A2Cleared 510(K)
- K942058SPACELABS MEDICAL ECG MODULE (MODEL 90492)2Cleared 510(K)
- K9453841481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED2Cleared 510(K)
- K944350SC 6000/ SC 6000P/ R502Cleared 510(K)
- K933177SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS2Cleared 510(K)
- K942147PACIFIC COMMUNICATIONS MODEL 11002Cleared 510(K)
- K935846MODEL ACUITY CENTRAL STATION2Cleared 510(K)
- K925510MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING2Cleared 510(K)
- K920790MARQUETTE EAGLE MONITOR2Cleared 510(K)
- K931716BATTERY PACK 1017LA2Cleared 510(K)
- K930095SPACELABS MEDICAL PATIENT MONITOR2Cleared 510(K)
- K923747CC ARHYTHMIS MONITORING OPTION2Cleared 510(K)
- K925411MODEL 2041-PC/ST CARDIAC TELEMETRY MONITOR2Cleared 510(K)
- K922027AMBULATORY (HOLTER) RECORDING, MODIFICATION2Cleared 510(K)
- K920154BSM-8800A BEDSIDE MONITOR2Cleared 510(K)
- K924672ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY)2Cleared 510(K)
- K920743DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS2Cleared 510(K)
- K914092BSM-2100A CONFIGURED PATIENT MONITOR2Cleared 510(K)
- K913117ZB-860PA MULTIPARAMETER TRANSMITTER2Cleared 510(K)
- K915153ESCORT-LINK ARRHYTHMIA OPTION 23L2Cleared 510(K)
- K910929OHMEDA MODULUS CD ANESTHESIA SYSTEM WITH C.V.2Cleared 510(K)
- K911835RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM2Cleared 510(K)
- K913576DATASCOPE MODEL VISA CENTRAL MONITOR2Cleared 510(K)
- K913339HORIZON PACEMAKER DETECTION SOFTWARE2Cleared 510(K)
- K912744ORG-8200A UNIVERSAL SIGNAL HOUSING2Cleared 510(K)
- K903940TYPE 9210 S/ECG2Cleared 510(K)
- K913451HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS2Cleared 510(K)
- K910109CARDIOSWISS CM-82Cleared 510(K)
- K905506ACCUCORE TELEMETRY, MODIFICATION2Cleared 510(K)
- K910808Q-SMART HOLTER SYSTEMS2Cleared 510(K)
- K900385ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE2Cleared 510(K)
- K910490MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A2Cleared 510(K)
- K900366ARRHYTHMIA 92152Cleared 510(K)
- K910291MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION2Cleared 510(K)
- K903514FUKUDA DENSHI MODEL LX-31002Cleared 510(K)
- K900720MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)2Cleared 510(K)
- K900607MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.112Cleared 510(K)
- K903704FUKUDA DENSHI MODEL FCP-2201 MODIFICATION2Cleared 510(K)
- K900540TRAM PATIENT MONITOR2Cleared 510(K)
- K900246CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 5122Cleared 510(K)
- K900319SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM2Cleared 510(K)
- K897074MODEL 215M PATIENT SIMULATOR2Cleared 510(K)
- K896775PCI MODEL 2041-B TELEMETRY MONITOR2Cleared 510(K)
- K896862MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM2Cleared 510(K)
- K895806ELATEC HOLTER ANALYZER2Cleared 510(K)
- K896967HTS 820 CARDIAC MONITOR2Cleared 510(K)
- K895547GRANDCOR/CARDIOLINE ECT STRESS TESTING2Cleared 510(K)
- K896771EKG, ECG KENZ, ECG 3022Cleared 510(K)
- K894543MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER2Cleared 510(K)
- K897063FUKUDA DENSHI MODEL DS-3300 ETR2Cleared 510(K)
- K895266AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED2Cleared 510(K)
- K896103MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR2Cleared 510(K)
- K894628MODEL DS-3300 DYNASCOPE PATIENT MONITOR2Cleared 510(K)
- K895208ZYMED MODEL 16102Cleared 510(K)
- K8846431100 VITAL SIGNS MONITOR2Cleared 510(K)
- K894858CARE 5000 SYSTEM2Cleared 510(K)
- K894692BEDSIDE MONITORS, BSM-8301A, BSM-8302A2Cleared 510(K)
- K894460SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA2Cleared 510(K)
- K894285DMI PC HOLTER SCANNER2Cleared 510(K)
- K882818SEER2Cleared 510(K)
- K890323MAX-1 (EXERCISE ELECTROCARDIOGRAPH)2Cleared 510(K)
- K885256MEDILOG EXCEL ECG ANALYSIS SYSTEM2Cleared 510(K)
- K891148MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM2Cleared 510(K)
- K890330MEDILOG 6000-FD REPORT GENERATOR2Cleared 510(K)
- K890338MEDILOG EDITOR2Cleared 510(K)
- K885204HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)2Cleared 510(K)
- K884524HTS 220 CARDIAC MONITOR2Cleared 510(K)
- K882206SUPERMON ARRHYTHMIA MODULE 72702Cleared 510(K)
- K884216506 NON-INVASIVE VITAL SIGNS MONITOR2Cleared 510(K)
- K884106SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL2Cleared 510(K)
- K884887MODEL 499 SSR ANALYSIS SYSTEM2Cleared 510(K)
- K884539HOLTER 24-HOUR ECG PLAYBACK, MODEL 1502Cleared 510(K)
- K883440E550 ELECTROCARDIOGRAPH2Cleared 510(K)
- K880505ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-3012Cleared 510(K)
- K884152CENTURY COLOR TRACE2Cleared 510(K)
- K882978Q4000 OPTION FOR Q40002Cleared 510(K)
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- K883103EPICARDIA PC/FC2Cleared 510(K)
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- K881905MODEL MICRO SI AMBULATORY ECG MONITOR2Cleared 510(K)
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- K862947THE EXPERT MODELS RTS 2000 AND RTS 2000H2Cleared 510(K)
- K871344PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR2Cleared 510(K)
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- K864506SPACELABS - ARRHYTHMIA NET (TM) LEVEL 12Cleared 510(K)
- K864505SPACELABS ARRHYTHMIA NET (TM) LEVEL 22Cleared 510(K)
- K863724MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM2Cleared 510(K)
- K862316CASE 122Cleared 510(K)
- K863159Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR2Cleared 510(K)
- K862375CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM2Cleared 510(K)
- K860980PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III2Cleared 510(K)
- K861240BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER2Cleared 510(K)
- K860950SCM-400 HOLTER SYSTEM2Cleared 510(K)
- K852250595 ARRHYTHMIA MONITORING SYSTEM2Cleared 510(K)
- K860471DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER2Cleared 510(K)
- K860470DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST2Cleared 510(K)
- K860834SPACELABS MEDICAL WORKSTATION2Cleared 510(K)
- K860767MODEL E 600 ELECTROCARDIOGRAPH2Cleared 510(K)
- K860167PRODIGY AND PRODIGY PLUS2Cleared 510(K)
- K860024FUKUDA DENSHI CARDIMAX FCP-2112Cleared 510(K)
- K853669MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL2Cleared 510(K)
- K860079MEDILOG 4500 SYSTEM2Cleared 510(K)
- K860078MEDILOG 2500 SYSTEM2Cleared 510(K)
- K855094FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA2Cleared 510(K)
- K854115CUSTO PORT 24-H ECG AMBULATORY RECORDER2Cleared 510(K)
- K854282PREVIEW XT2Cleared 510(K)
- K852892MEDILOG M62Cleared 510(K)
- K852654CARDIAC COMMUNICATOR 20002Cleared 510(K)
- K853352FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR2Cleared 510(K)
- K852968PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM2Cleared 510(K)
- K853209COMPAS 12Cleared 510(K)
- K853213FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON2Cleared 510(K)
- K851517CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO2Cleared 510(K)
- K852514MODEL 78560A CENTRAL STATION PATIENT INFO SYS2Cleared 510(K)
- K852270LIFESCOPE 8 DEC-8108A AND DEC-8204A2Cleared 510(K)
- K851702MORTARA INSTRUMENT MODEL EL-12Cleared 510(K)
- K852884MEDILOG M12Cleared 510(K)
- K852883MEDILOG M32Cleared 510(K)
- K843731KENZ 80Z MARK II2Cleared 510(K)
- K852207OXFORD VDT-40 DISPLAY TERMINAL2Cleared 510(K)
- K850897FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES2Cleared 510(K)
- K844791SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A2Cleared 510(K)
- K844464PROGRAMMABLE PATIENT SIMULATOR2Cleared 510(K)
- K842976BRENTWOOD EZ SCAN 200 AMBULATORY ECG2Cleared 510(K)
- K841083QUIKPAGE ARRHYTHMIA REPORT GENERATOR2Cleared 510(K)
- K850136CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM2Cleared 510(K)
- K841084ARRHYTHMIA SYSTEM AC-112Cleared 510(K)
- K823844HORIZON ECG SYSTEM2Cleared 510(K)
- K840899SERVOMED ARRHYCOMP CENTRAL MONITOR SYS2Cleared 510(K)
- K842715DOCUMENTOR2Cleared 510(K)
- K842123PERSONAL CL SINGLE-CHANNEL ELECTROCAR2Cleared 510(K)
- K843503AEGIS AMBULATORY MONITORING SYSTEM2Cleared 510(K)
- K843513EPICARDIA, PC2Cleared 510(K)
- K843287ARRHYTHMIA CENTRAL OCC-71012Cleared 510(K)
- K842616SPACELABS ALPHA PC PATIENT COMPUTER2Cleared 510(K)
- K841416PEDIATRIC DIAG. CRITERIA OPTION 5600C2Cleared 510(K)
- K842640SPACELABS ICR ARRHYTHMIA MASTER I HOLTER2Cleared 510(K)
- K841500LIFESCOPE 6 OEC-62012Cleared 510(K)
- K841172MONITOR ONE2Cleared 510(K)
- K840622CARDIO EXPRESS 100 HOLTER SCANNER2Cleared 510(K)
- K834211LEAP FROG2Cleared 510(K)
- K834597ALPHA MASS STORAGE CARDULE 18952Cleared 510(K)
- K834397HOLTER CARDIOGRAPHY SYS 62012Cleared 510(K)
- K832354HOLTA-MED INFORMER PLAYBACK2Cleared 510(K)
- K833162AMBULATORY MONITORING DEVICE2Cleared 510(K)
- K831676BIOSENSOR ASC SYSTEM2Cleared 510(K)
- K831638SINGLE BED ARRHYTHMIA MONITOR AM5002Cleared 510(K)
- K832693ARRHYTHMIA III CARDULE #19192Cleared 510(K)
- K832772SATURN-24HR. HOLTER SCANNER2Cleared 510(K)
- K831274WLECTROCARDIOGRAPH ECG-72042Cleared 510(K)
- K830830CIRCA MED TWO-CHANNEL2Cleared 510(K)
- K823585COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-132Cleared 510(K)
- K823586COMPUTER-AIDED ELECTROCARDIOGRAPH FCP2002Cleared 510(K)
- K830029SIRECUST 4002Cleared 510(K)
- K830407ECLIPSE2Cleared 510(K)
- K830306HEARTRATE PLUS ECG CARDULE #19182Cleared 510(K)
- K830013EPI CARDIA SYS. - AMBULATORY MONITOR2Cleared 510(K)
- K830163IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS2Cleared 510(K)
- K822968ELECTROCARDIOGRAPH INTERPRETER2Cleared 510(K)
- K822616LS6 ARRYTHMIA DISCRIMINATOR2Cleared 510(K)
- K822718SERIES 7000 BEDSIDE PATIENT MONITOR2Cleared 510(K)
- K821711CARDIO TEHCHANALYZER2Cleared 510(K)
- K822030MULTIPLE LEAD ARRHYTHMIA MODULE2Cleared 510(K)
- K820881MEMOPORT C2Cleared 510(K)
- K820856EVENTMASTER 22Cleared 510(K)
- K820438QUINTON Q2000 ETT MONITORING SYSTEM2Cleared 510(K)
- K820477ALGORITHM OF THE ARRHYTHMIA MON. SYS2Cleared 510(K)
- K812914MICRO-PREPROCESSOR UNIT2Cleared 510(K)
- K813287CC-201 ECG MONITORING SYSTEMS2Cleared 510(K)
- K812149CARDIO-DATA SYSTEM, #MARK III2Cleared 510(K)
- K811581ARRHYTHMIA FUNCTION BLOCK2Cleared 510(K)
- K810940THE BETA2Cleared 510(K)
- K811792ARRYTHMIA PRINTER OPTION2Cleared 510(K)
- K811527CC-1032Cleared 510(K)
- K811122DEL MAR AVIONICS MODELS 9400 & 94012Cleared 510(K)
- K803208SIRECUST 3582Cleared 510(K)
- K810027DATAMEDIX PECGASYS SYSTEM2Cleared 510(K)
- K802900HEART SENTINEL2Cleared 510(K)
- K801903SERIES 4000 STRESS & EXERCISE SYSTEM2Cleared 510(K)
- K803282GUARDIAN MONITOR (CARDIOVASCULAR)2Cleared 510(K)
- K802312CC101 ECG MONITORING SYSTEM2Cleared 510(K)
- K802472BIOMETRIC ERG SYSTEM2Cleared 510(K)
- K802272COMPUTER ECG TERMINAL2Cleared 510(K)
- K802103ECG RECALL & EDIT PRODUCT VERSION-A36012Cleared 510(K)
- K802033OXFORD INTENSIVE CARE PATIENT MON. SYS2Cleared 510(K)
- K801831EVALUATOR #9500 DYNAMIC ELEC/SCANNER2Cleared 510(K)
- K801762MICRO-PROCESSOR UNIT #A3600AC2Cleared 510(K)
- K792081SPECTRA CENTRAL PT MONITORING SYS2Cleared 510(K)
- K791632COMPU-SCAN2Cleared 510(K)
- K791487MODEL 78520A ARRHYTHMIA MONITORING SYS2Cleared 510(K)
- K791424DCG-VII ELECTROCARDIOSCANNER2Cleared 510(K)
- K790837ARRHYTHMIA II CARDULE2Cleared 510(K)
- K790287ANALYZER, MEDILOG II2Cleared 510(K)
- K781911ECG ANALYZER, HIGH SPEED2Cleared 510(K)
- K781845CAMSCAN SYSTEM2Cleared 510(K)
- K780432ARRHYTHMIA PROGRAM MODULE2Cleared 510(K)
- K780343ARRHYTHMIA TREND ENHANCEMENT2Cleared 510(K)
- K772360ARRHYTHMIA MODULE2Cleared 510(K)
- K771374SCANNER TREND SYSTEM2Cleared 510(K)
- K760368MONITORING & STRESS TESTING EQUIPMENT2Cleared 510(K)
- K760884MICRO-COMPUTER ARRHYTHONIA SYSTEM2Cleared 510(K)
- DSJAlarm, Blood-Pressure2Product Code
- DSKComputer, Blood-Pressure2Product Code
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function2Product Code
- DXLInjector, Indicator2Product Code
- DXMDensitometer2Product Code
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive2Product Code
- DXQBlood Pressure Cuff2Product Code
- DXWSystem, Phonocatheter, Intracavitary2Product Code
- DXXSystem, Catheter Control, Steerable2Product Code
- DYBIntroducer, Catheter2Product Code
- DYGCatheter, Flow Directed2Product Code
- JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)2Product Code
- KRACatheter, Continuous Flush2Product Code
- KRBProbe, Thermodilution2Product Code
- KRKManometer, Blood-Pressure, Venous2Product Code
- LDEStethoscope, Manual1Product Code
- LITCatheter, Angioplasty, Peripheral, Transluminal2Product Code
- MAVSyringe, Balloon Inflation2Product Code
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2Product Code
- MLDMonitor, St Segment With Alarm2Product Code
- MTDCatheter, Intracardiac Mapping, High-Density Array2Product Code
- MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)2Product Code
- NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection2Product Code
- NKQGuidewire, Catheter, Reprocessed2Product Code
- NKRSystem, Catheter Control, Reprocessed2Product Code
- NKSCatheter, Steerable, Reprocessed2Product Code
- NKUInjector And Syringe, Angiographic, Balloon Inflation, Reprocessed2Product Code
- NKWActuator, Syringe, For Injector, Reprocessed2Product Code
- NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed2Product Code
- NLHCatheter, Recording, Electrode, Reprocessed2Product Code
- NLICatheter, Angiography, Reprocessed2Product Code
- NMBCatheter, Oximeter, Fiber Optic, Reprocessed2Product Code
- NMKTrocar, Reprocessed2Product Code
- NMMCatheter, Angioplasty, Peripheral, Transluminal, Reprocessed2Product Code
- NPPReprocessed Blood Pressure Cuff2Product Code
- NTETemporary Carotid Catheter For Embolic Capture2Product Code
- NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon2Product Code
- OBICatheter, Pressure Monitoring, Cardiac2Product Code
- OBJCatheter, Ultrasound, Intravascular2Product Code
- OEDAntimicrobial Blood Pressure Cuff2Product Code
- OEQAngiography/Angioplasty Kit2Product Code
- OERAngioscopic Valvulotome Kit2Product Code
- OESCardiac Catheterization Kit2Product Code
- OEXCardiovascular Catheter Sheath Introducer Kit2Product Code
- OEZCardiovascular Procedure Kit2Product Code
- OFBCatheter Guide Wire Kit2Product Code
- OFCCatheter Introducer Kit2Product Code
- OFDCatheter Introducer Kit2Product Code
- OFECentral Venous Blood Pressure Kit2Product Code
- OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter2Product Code
- OFFCentral Venous Catheter Tray2Product Code
- OFHDigital Angiography Tray2Product Code
- ORDOptical Coherence Tomography, Intravascular Catheter2Product Code
- OFJLead Introducer Kit2Product Code
- OFKPercutaneous Atrial Catheter Kit2Product Code
- OFLPercutaneous Sheath Introducer Kit2Product Code
- OFNWinged Intravenous Catheterization Kit2Product Code
- OGZCatheter, Intravascular, Plaque Morphology Evaluation2Product Code
- OWQReprocessed Intravascular Ultrasound Catheter2Product Code
- OZTBalloon Aortic Valvuloplasty2Product Code
- PDUCatheter For Crossing Total Occlusions2Product Code
- PFANon-Invasive Central Venous Manometer2Product Code
- PJACoronary Vascular Physiologic Simulation Software2Product Code
- PNEReprocessed Catheter Introducer2Product Code
- PNOCatheter, Percutaneous, Cutting/Scoring2Product Code
- PPNPercutaneous Catheter, Ultrasound2Product Code
- PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access2Product Code
- PTLWire, Guide, Catheter, Exempt2Product Code
- PTMSyringe, Balloon Inflation, Exempt2Product Code
- PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures2Product Code
- QEKAngiographic Coronary Vascular Physiologic Simulation Software2Product Code
- QFJIntravascular Bleed Monitor2Product Code
- QJHReverse Central Venous Recanalization System2Product Code
- QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals2Product Code
- QQIInterventional Cardiovascular Implant Simulation Software Device2Product Code
- QYFNeonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)2Product Code
- QYWHospital Cardiac Telemetry2Product Code
- QYXOutpatient Cardiac Telemetry2Product Code
- 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
- Subpart F—Therapeutic DevicesCFR Sub-Part
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CS/3(TM) MONITORS*
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K974792
- 510(k) Type
- Traditional
- Applicant
- DATEX-ENGSTROM, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/2/1998
- Days to Decision
- 162 days
- Submission Type
- Statement