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
- 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
- K212003ESSENZ Patient Monitor2Cleared 510(K)
- K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)2Cleared 510(K)
- K201162Essence 55SP Large Monitor System2Cleared 510(K)
- K173107Vios Central Station Monitor Software, Vios Central Server Software2Cleared 510(K)
- K180534Philips IntelliVue GuardianSoftware2Cleared 510(K)
- K173381Nexxis OR2Cleared 510(K)
- K172969Essence 55S Large Monitor System2Cleared 510(K)
- K170460Sorin Connect2Cleared 510(K)
- K170537Nexxis OR, Nexxis2Cleared 510(K)
- K161880NIVR58-T kit2Cleared 510(K)
- K161767Philips IntelliVue GuardianSoftware2Cleared 510(K)
- K162012CARESCAPE Central Station V22Cleared 510(K)
- K151366Philips CS770 IntelliSpace Critical Care and Anesthesia2Cleared 510(K)
- K151736Philips IntelliVue GuardianSoftware2Cleared 510(K)
- K133994SIVR56-T KIT2Cleared 510(K)
- K133882CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)2Cleared 510(K)
- K132488ZOLL CODE WRITER2Cleared 510(K)
- K131272SIREN EPCR SUITE2Cleared 510(K)
- K131919ZOLL EPCR IOS2Cleared 510(K)
- K131816SORIN CONNECT DATA MANAGEMENT SYSTEM2Cleared 510(K)
- K122167NEXXIS OR2Cleared 510(K)
- K113214TLINK DATA MANAGEMENT SYSTEM (DMS)2Cleared 510(K)
- K111905INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 8652162Cleared 510(K)
- K112645RADIFORCE LARGE MONITOR SYSTEM2Cleared 510(K)
- K103473ZOLL RESCUENET EPCR MODEL RESCUENET EPCR2Cleared 510(K)
- K110085VANTAGE VIEW SYSTEM2Cleared 510(K)
- K101474MD VISION SYSTEM2Cleared 510(K)
- K100272INTELLIVUE CLINICAL INFORMATION PORTFOLIO2Cleared 510(K)
- K083321CARDIO-VIEW2Cleared 510(K)
- K073372ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)2Cleared 510(K)
- K053356MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION2Cleared 510(K)
- K013515INFINITY EXPLORER2Cleared 510(K)
- K001112GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC2Cleared 510(K)
- K992636HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A2Cleared 510(K)
- K942685ECG REVIEW STATION2Cleared 510(K)
- K962811SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION2Cleared 510(K)
- K945277HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR2Cleared 510(K)
- K934093580CDR DISPLAY DRIVER2Cleared 510(K)
- K932894620CSR DISPLAY DRIVER2Cleared 510(K)
- K926219516YT DISPLAY DRIVER2Cleared 510(K)
- K926162580CD DISPLAY DRIVER2Cleared 510(K)
- K932724SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY2Cleared 510(K)
- K905788MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM2Cleared 510(K)
- K901072CENTRALSCOPE 122Cleared 510(K)
- K902334MONITOR, MODEL 28172Cleared 510(K)
- K9018847620 REMOTE CENTRAL STATION REPEATER2Cleared 510(K)
- K884423HORIZON DISPLAY CONTROLLER PART # 266-200-0102Cleared 510(K)
- K890353SMDS460 SURGICAL MONITOR DISPLAY SYSTEM2Cleared 510(K)
- K883973MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A2Cleared 510(K)
- K883031Q-CATH RM2Cleared 510(K)
- K873774M300 MONITOR/CONTROLLER T500 TREADMILL2Cleared 510(K)
- K854372VM 781 SLAVE SCOPE2Cleared 510(K)
- K851496ECG MONITOR MODEL RM1022Cleared 510(K)
- K851628RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO2Cleared 510(K)
- K851400SIRECUST 420 PATIENT DIALOG MONITOR2Cleared 510(K)
- K850343DISPLAY MONITOR (VD-711RA-VD-712RA)2Cleared 510(K)
- K844650DR-2C2Cleared 510(K)
- K840209SERVOMED MEDIVISION SCOPE SMV-2352Cleared 510(K)
- K833819M3052Cleared 510(K)
- K832022SERVOMED SMC 108/111-426-24, 111-4262Cleared 510(K)
- K831783SERVOMED BASIC BEDSIDE UNIT SMV 1042Cleared 510(K)
- K831781SERVOMED BASIC BEDSIDE UNIT SMVIII W2Cleared 510(K)
- K831782SERVOMED BASIC BEDSIDE UNIT SMV 1072Cleared 510(K)
- K830899THREE CHANNEL MONITOR SERIES 67002Cleared 510(K)
- K822517SINGLE CHANNEL NONFADE OSCILLOSCOPE2Cleared 510(K)
- K82149135MM ANGIOGRAM VIEWER ANALYZER2Cleared 510(K)
- K811911SINGLE CHANNEL NON-FADE OSCILLOSCOPE2Cleared 510(K)
- K810164VC 430 VIDEO CONVERTER2Cleared 510(K)
- K810168SLAVE MONITORS DC109 & VS1092Cleared 510(K)
- K810165DUAL TRACE VIDEO MONITOR VM 4102Cleared 510(K)
- K803123CRT DISPLAY #1310B2Cleared 510(K)
- K801000LARGE SCREEN CRT DISPLAY #1311B2Cleared 510(K)
- K781256CATHODE RAY TUBE MED. DISPLAY2Cleared 510(K)
- K780782M. 1336S CATHODE-RAY TUBE DISPLAY2Cleared 510(K)
- K780425BIOPHYSICAL MONITORING SYSTEM2Cleared 510(K)
- K770279MONITOR, PORTABLE, PART #431-0102Cleared 510(K)
- K760721MEDICAL OSCILLOSCOPE MEMORY SCOPE2Cleared 510(K)
- K760523MONITOR SCOPE2Cleared 510(K)
- 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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TLINK DATA MANAGEMENT SYSTEM (DMS)
- Page Type
- Cleared 510(K)
- 510(k) Number
- K113214
- 510(k) Type
- Traditional
- Applicant
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/7/2012
- Days to Decision
- 99 days
- Submission Type
- Summary