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
- K252440EasyTeleMed (2.0.2)2Cleared 510(K)
- K250259TeleRehab Aermos Cardiopulmonary Rehabilitation2Cleared 510(K)
- K243837iBSM2Cleared 510(K)
- K242018UbiqVue™ 2A Multi-parameter System (UX2550)2Cleared 510(K)
- K241101BioButton System2Cleared 510(K)
- K240251ANNE Chest2Cleared 510(K)
- K223711ANNE One2Cleared 510(K)
- K220526HD+12, HD+152Cleared 510(K)
- K223073Alio2Cleared 510(K)
- K222398Care Team Portal2Cleared 510(K)
- K212957BioButton System2Cleared 510(K)
- K221530ANNE Pediatric2Cleared 510(K)
- K212883ers2 - ergoline Rehabilitation System2Cleared 510(K)
- K213233EZYPRO ECG Recorder (Model: UG02)2Cleared 510(K)
- K211365Alio Medical Remote Monitoring System2Cleared 510(K)
- K211822LifePath Remote Patient Monitoring Platform2Cleared 510(K)
- K211305ANNE One2Cleared 510(K)
- K202868LifeSignals Multi-Parameter Remote Monitoring Platform2Cleared 510(K)
- K200690LifeSignals ECG Remote Monitoring Patch Platform2Cleared 510(K)
- K191620Vitls Platform2Cleared 510(K)
- K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)2Cleared 510(K)
- K192875Philips Biosensor BX1002Cleared 510(K)
- K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 202Cleared 510(K)
- K191870VV330 Continuous ECG Platform, VivaLNK Adhesive Patch2Cleared 510(K)
- K191614BioSticker System2Cleared 510(K)
- K191331Life Sensor Cardiac Monitor2Cleared 510(K)
- K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 202Cleared 510(K)
- K183078VitalConnect Platform, VitalPatch Biosensor2Cleared 510(K)
- K182297Surveyor S22Cleared 510(K)
- K181248Comarch e-Care Platform2Cleared 510(K)
- K181196Caretaker Remote Display App and Caretaker Software Library2Cleared 510(K)
- K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)2Cleared 510(K)
- K171019ScioCardio ECG Transmitter2Cleared 510(K)
- K173510BioStamp nPoint2Cleared 510(K)
- K172329Patient Status Engine2Cleared 510(K)
- K163694Rooti Rx ECG Event Recorder, Rooti Link APP Software2Cleared 510(K)
- K163453VitalPatch® VitalConnect Platform2Cleared 510(K)
- K171406Optum TeleHealth Application2Cleared 510(K)
- K171029eCareCoordinator2Cleared 510(K)
- K171188Ossler Exam Scope2Cleared 510(K)
- K170973VitalWatch Software User Interface2Cleared 510(K)
- K170204FFR Link, FFR Signal Processing Module2Cleared 510(K)
- K161916TelePatch Cardiac Monitor2Cleared 510(K)
- K153719LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream2Cleared 510(K)
- K152139Vital Connect Platform, HealthPatch MD, VitalPatch2Cleared 510(K)
- K150289CARDIOLINE HD+2Cleared 510(K)
- K141020SURVEYOR S4 MOBILE MONITOR2Cleared 510(K)
- K141792GENESIS TOUCH SYSTEM2Cleared 510(K)
- K133997LG SMARTHEALTH2Cleared 510(K)
- K141706ECARE COORDINATOR (ECC)2Cleared 510(K)
- K141167VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)2Cleared 510(K)
- K132173FAMILY HEALTHWARE2Cleared 510(K)
- K132930MYHEALTHPOINT TELEHEALTH MANAGER2Cleared 510(K)
- K132447VITALCONNECT PLATFORM BY VITAL CONNECT INC.2Cleared 510(K)
- K133252HEALTHINTERLINK BEACON2Cleared 510(K)
- K134004VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE2Cleared 510(K)
- K133587PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 3002Cleared 510(K)
- K132803MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK2Cleared 510(K)
- K132148S HEALTH2Cleared 510(K)
- K131913INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC2Cleared 510(K)
- K130971OPTUM TELEHEALTH APPLICATION2Cleared 510(K)
- K130821INTEL-GE CARE INNOVATIONS CONNECT RCM2Cleared 510(K)
- K124000MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM2Cleared 510(K)
- K122458VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM2Cleared 510(K)
- K130360CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION2Cleared 510(K)
- K130676AMBIO REMOTE HEALTH MONITORING SYSTEM2Cleared 510(K)
- K122763PHYSIOLOGICAL DATA PROCESSOR2Cleared 510(K)
- K130290MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE2Cleared 510(K)
- K123671WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM2Cleared 510(K)
- K123229REMOTE PRESENCE SYSTEM, MODEL RP-VITA2Cleared 510(K)
- K122333MOBILECARE MONITOR2Cleared 510(K)
- K122285TABLET COMMANDER2Cleared 510(K)
- K122095ICP TRIAGEMANAGER2Cleared 510(K)
- K120325CONNECTED CARE MOBILE APPLICATION2Cleared 510(K)
- K120253ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)2Cleared 510(K)
- K113446VIGNET TELEHEALTH MANAGER2Cleared 510(K)
- K120941CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM2Cleared 510(K)
- K120470MIPAL2Cleared 510(K)
- K120895REMOTE PRESENCE SYSTEM2Cleared 510(K)
- K1207043M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM2Cleared 510(K)
- K112858GENESIS TOUCH SYSTEM2Cleared 510(K)
- K113493TCX-I REMOTE CARE MANAGEMENT SYSTEM2Cleared 510(K)
- K112559MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM2Cleared 510(K)
- K111922VOCARE MYHEALTH TABLET2Cleared 510(K)
- K111854AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER2Cleared 510(K)
- K103643ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)2Cleared 510(K)
- K103796TELEMEDCARE HEALTH MONITOR2Cleared 510(K)
- K110809WIRELESS MONITORING SYSTEM2Cleared 510(K)
- K110334WALDO PATIENT MONITOR2Cleared 510(K)
- K103276INTEL HEALTH GUIDE2Cleared 510(K)
- K102106NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION2Cleared 510(K)
- K103214M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED1302Cleared 510(K)
- K1018343M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM2Cleared 510(K)
- K101178MODIFICATION TO INTEL HEALTH GUIDE PHS60002Cleared 510(K)
- K101242GENESIS DM MODEL: 6053000A12Cleared 510(K)
- K100427FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY2Cleared 510(K)
- K100524POLYTEL(R) APT MODEL: PWA-08-012Cleared 510(K)
- K093895ALLY PLATFORM SYSTEM2Cleared 510(K)
- K101078BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM2Cleared 510(K)
- K100508CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B2Cleared 510(K)
- K093134CERNER CAREAWARE IBUS2Cleared 510(K)
- K091696SAVI WIRELESS, MODEL PM5002Cleared 510(K)
- K091220HEALTHANYWHERE SYSTEM2Cleared 510(K)
- K092635ALCATEL-LUCENT TELEHEATH MANAGER2Cleared 510(K)
- K091430CARE PAL, MODEL CPW-10X2Cleared 510(K)
- K091021MODIFICATION TO MEDICOMPASS CONNECT2Cleared 510(K)
- K083862MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM2Cleared 510(K)
- K090886RTX 33712Cleared 510(K)
- K090801ELECTRONIC HOUSE CALL2Cleared 510(K)
- K090610HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM2Cleared 510(K)
- K083046FORA TELEHEALTH SYSTEM2Cleared 510(K)
- K081499HEALTH MANAGER, VERSION 1.12Cleared 510(K)
- K083331CONFIDANT, MODEL 2.62Cleared 510(K)
- K083115MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS60002Cleared 510(K)
- K080798INTEL HEALTH GUIDE, MODEL: PHS60002Cleared 510(K)
- K073710INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-72Cleared 510(K)
- K080091MODIFICATION TO:HEALTH BUDDY APPLIANCE2Cleared 510(K)
- K073038CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B2Cleared 510(K)
- K072698CONFIDANT 2.52Cleared 510(K)
- K072008BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER2Cleared 510(K)
- K071564MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 4535640369212Cleared 510(K)
- K071953RTX33702Cleared 510(K)
- K071058MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A2Cleared 510(K)
- K070543MODIFICATION TO HEALTH BUDDY APPLIANCE2Cleared 510(K)
- K063612MODIFICATION TO HEALTH BUDDY APPLIANCE2Cleared 510(K)
- K063484PATIENT DATA HANDLER & DEVICES (PDH&D)2Cleared 510(K)
- K062662TELEMEDICINE SYSTEM MODEL VMS-012Cleared 510(K)
- K062127MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP)2Cleared 510(K)
- K062215CONFIDANT 2.02Cleared 510(K)
- K062304DLM112 DAYLINK MONITOR2Cleared 510(K)
- K061502MEDIC4ALL TELEMEDICINE SYSTEM VMS-012Cleared 510(K)
- K061606DEFIBRILLATOR CABLE TESTER, MODEL DT22002Cleared 510(K)
- K061087GENESIS OTC MONITOR2Cleared 510(K)
- K061088SENTRY OTC MONITOR2Cleared 510(K)
- K052608TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)2Cleared 510(K)
- K052961THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN2Cleared 510(K)
- K051470REMOTE CARE MANAGEMENT SYSTEMS (RCMS)2Cleared 510(K)
- K050929THE HERMES SYSTEM2Cleared 510(K)
- K050128VITALWARE VMS2Cleared 510(K)
- K050778TELEREHAD 20042Cleared 510(K)
- K050567HEALTH BUDDY APPLIANCE2Cleared 510(K)
- K041816RTX3320PSTN WIRELESS TELEHEALTH GATEWAY2Cleared 510(K)
- K040663TELENABLE EMS SYSTEM2Cleared 510(K)
- K040966MODIFICATION TO CAREMATIX WELLNESS SYSTEM2Cleared 510(K)
- K030222NX SYSTEM2Cleared 510(K)
- K030795LIFESYNE SYSTEMS2Cleared 510(K)
- K022274CARECOMPANION PATIENT STATION & NURSE STATION2Cleared 510(K)
- K023749THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)2Cleared 510(K)
- K013533EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)2Cleared 510(K)
- K002514CADHEALTH SYSTEM, MODEL CHP-0012Cleared 510(K)
- K002089ROSETTA-LT/ROSETTA-RX2Cleared 510(K)
- K000276MPT 24 AND VITAL VIEW 242Cleared 510(K)
- K993550AVIVA SYSTEM, MODEL SL10102Cleared 510(K)
- K993169MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A2Cleared 510(K)
- K981533AVIVA SYSTEMS MODEL NUMBERS 1010, 20202Cleared 510(K)
- K974149AMBULATORY X-12 TELEMETRY MODULE2Cleared 510(K)
- K973873DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 12Cleared 510(K)
- K964554PERSONAL TELEMEDICINE MODULE2Cleared 510(K)
- K946175NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER2Cleared 510(K)
- K945578NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER2Cleared 510(K)
- K940009GEMSCOM SERIES 6000, MODELS 6100, 6200 & 63002Cleared 510(K)
- K945037SIEMENS 1481 T TRANSMITTER, ENHANCED2Cleared 510(K)
- K935839GEMSCOM SERIES 5000,2Cleared 510(K)
- K934711PROPAQ ECG TELEMETRY OPTION2Cleared 510(K)
- K914889GEMSCOM SERIES 30002Cleared 510(K)
- K910620CARDIOCAP DR-124 RECORDER2Cleared 510(K)
- K904748TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 71002Cleared 510(K)
- K891104CD TELEMETRY SYSTEMS2Cleared 510(K)
- K880036BIOMA 50002Cleared 510(K)
- K873672MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR2Cleared 510(K)
- K860239ORG-7201 MULTIPARAMETER TELEMETRY MONITOR2Cleared 510(K)
- K851302QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR2Cleared 510(K)
- K850166TELEMANOMETER2Cleared 510(K)
- K844376MODEL 78210A TELEMETRY TRANSMITTER2Cleared 510(K)
- K832817TELEMETRY SYS SERIES 7700 ECG2Cleared 510(K)
- K823906TELEMETRY SYSTEM2Cleared 510(K)
- K823249LIFESCOPE II/FOUR2Cleared 510(K)
- K821384EXERCISE ECG ELECTRODES, REUSABLE2Cleared 510(K)
- K813064TELEMETRY TRANSMITTER & RECEIVER2Cleared 510(K)
- K810331DUO-TEL2Cleared 510(K)
- K802357TELEMETRY PACEMAKER MONITOR2Cleared 510(K)
- K8032294-CHANNEL ECG TELEMETRY MON. SYST. #30452Cleared 510(K)
- K802849TECNOL TELEMETRY UNIT POUCH2Cleared 510(K)
- K801944MULTICHANNEL TELEMETRY SYSTEM2Cleared 510(K)
- K802273TELEMETRY TRANSMITTER, #TLT-32Cleared 510(K)
- K791363KWIK-AWA VEST2Cleared 510(K)
- K790109TELEMETRY, BIOMEDICAL2Cleared 510(K)
- K790144TELEMETRY SYSTEM 3152Cleared 510(K)
- K781836TELEMETRY SYSTEM, BIOTEL 3002Cleared 510(K)
- K772000ECG TELEMETRY SYSTEM2Cleared 510(K)
- 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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Rooti Rx ECG Event Recorder, Rooti Link APP Software
- Page Type
- Cleared 510(K)
- 510(k) Number
- K163694
- 510(k) Type
- Traditional
- Applicant
- Rooti Labs Ltd.
- Country
- Taiwan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/7/2017
- Days to Decision
- 314 days
- Submission Type
- Summary