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
- 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
- K242842ANNE View, Central Hub2Cleared 510(K)
- K241397Hinscope2Cleared 510(K)
- K233834Infinity Gateway Suite2Cleared 510(K)
- K233418Biofourmis Everion+ (G2)2Cleared 510(K)
- K232548Corsano CardioWatch 287-2 System2Cleared 510(K)
- K231506Current Health System2Cleared 510(K)
- K223567CNS-2101 Central Monitor2Cleared 510(K)
- K213863Everion+ System2Cleared 510(K)
- K222550Current Health System2Cleared 510(K)
- K203579Infinity Gateway Suite2Cleared 510(K)
- K211046eCareManager 4.52Cleared 510(K)
- K220058BeneVision Central Monitoring System2Cleared 510(K)
- K212622Zyter RPM2Cleared 510(K)
- K211949AirStrip ONE Web Client with Alarm Communication Management (ACM)2Cleared 510(K)
- K210160AlertWatch:AC2Cleared 510(K)
- K210133Current Health Monitoring System Gen 2 (G2)2Cleared 510(K)
- K202497Aulisa Multiple Patient Digital Vital Sign Monitoring System2Cleared 510(K)
- K193421Smart Alarm Interface2Cleared 510(K)
- K192952Spire Health Remote Patient Monitoring System2Cleared 510(K)
- K193391BeneVision Central Monitoring System2Cleared 510(K)
- K193043Critical Alert CommonPath Enterprise2Cleared 510(K)
- K191272Wearable Device, Wearable Package2Cleared 510(K)
- K182637Philips IntelliVue XDS Software2Cleared 510(K)
- K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub2Cleared 510(K)
- K183238BeneVision Central Monitoring System2Cleared 510(K)
- K180430Digistat Smart Central2Cleared 510(K)
- K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package2Cleared 510(K)
- K180566Unite Connect for Clinical Systems2Cleared 510(K)
- K173203Athena GTX Device Management Suite (ADMS) Software2Cleared 510(K)
- K171322eCareManager 4.12Cleared 510(K)
- K162607BeneVision Central Monitoring System2Cleared 510(K)
- K153156eCareManager 4.0.12Cleared 510(K)
- K160862AirStrip RPM2Cleared 510(K)
- K161164CareEvent inclusive of the CareEvent Mobile Application accessory2Cleared 510(K)
- K151672Cerner CareAware Event Management2Cleared 510(K)
- K151006EarlySense Central Display Station (CDS)2Cleared 510(K)
- K150632Hypervisor IX Monitoring System2Cleared 510(K)
- K140852VECTRAPLEX CMS2Cleared 510(K)
- K142935CareEvent2Cleared 510(K)
- K141756INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION2Cleared 510(K)
- K143057M3290B Philips IntelliVue Information Center iX2Cleared 510(K)
- K132036HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)2Cleared 510(K)
- K130707ISIRONA MAGELLAN2Cleared 510(K)
- K130339CLINICAL ALERT NOTIFICATION2Cleared 510(K)
- K121865ZOLL RESCUENET 12-LEAD2Cleared 510(K)
- K121712AIRSTRIP RPM FOR LIFENET CONSULT2Cleared 510(K)
- K121885EARLYSENSE CENTRAL DISPLAY SYSTEM2Cleared 510(K)
- K112650CONNEXALL SUITE OF SOFTWARE PRODUCTS2Cleared 510(K)
- K112282M VISUM ALERT ALARM MANAGEMENT SYSTEM2Cleared 510(K)
- K111296ZOLL RESCUENETLINK2Cleared 510(K)
- K112047AMCOM COMMTECH MESSENGER2Cleared 510(K)
- K111215ASCOM MOBILE MONITORING GATEWAY (MMG)2Cleared 510(K)
- K110521EVERON CENTRAL DISPLAY STATION (CDS)2Cleared 510(K)
- K103634ASCOM CLINICALCONNEX CARDIOMAX2Cleared 510(K)
- K102974INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.002Cleared 510(K)
- K102757LIFENET SYSTEM2Cleared 510(K)
- K100376EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.02Cleared 510(K)
- K093925LIFENET SYSTEM2Cleared 510(K)
- K091176PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 8614412Cleared 510(K)
- K080192HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)2Cleared 510(K)
- K071391PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 9898031425212Cleared 510(K)
- K071047MASIMO PATIENT SAFETY NET2Cleared 510(K)
- K070204LINK TO ACUITY CLINICIAN NOTIFIER2Cleared 510(K)
- K070421DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..022Cleared 510(K)
- K061428PMP4 APPLICATION2Cleared 510(K)
- K062278SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 918472Cleared 510(K)
- K061932BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE2Cleared 510(K)
- K061994WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE2Cleared 510(K)
- K060254MODIFICATION TO INFINITY EXPLORER2Cleared 510(K)
- K052975DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE2Cleared 510(K)
- K052854LIFENET EXCHANGE SYSTEM2Cleared 510(K)
- K052972DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.32Cleared 510(K)
- K051634DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION2Cleared 510(K)
- K051283MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE2Cleared 510(K)
- K042845THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS2Cleared 510(K)
- K042771GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.32Cleared 510(K)
- K040945MODIFICATION TO INFINITY EXPLORER2Cleared 510(K)
- K033281DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE2Cleared 510(K)
- K033078DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE2Cleared 510(K)
- K032582UNITY NETWORK PATIENT DATA SERVER2Cleared 510(K)
- K032346UNITY NETWORK IS PATIENT VIEWER2Cleared 510(K)
- K030615INFINITY EXPLORER2Cleared 510(K)
- K023497DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE2Cleared 510(K)
- K022507DATEX-OHMEDA S/5 NETWORK AND CENTRAL '022Cleared 510(K)
- K020661UNITY IS PATIENT VIEWER2Cleared 510(K)
- K020524PATIENTNET MONITORING SYSTEM2Cleared 510(K)
- K020018MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE2Cleared 510(K)
- K013387DATEX-OHMEDA S/5 WEB VIEWER2Cleared 510(K)
- K013246DATEX-OHMEDA S/5 NETWORK AND CENTRAL '012Cleared 510(K)
- K012531DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX2Cleared 510(K)
- K013156MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM2Cleared 510(K)
- K012171MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS2Cleared 510(K)
- K011999MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM2Cleared 510(K)
- K012005MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM2Cleared 510(K)
- K010912ALARMVIEW WIRELESS DATA NETWORK SYSTEM2Cleared 510(K)
- K003998FLEXVIEW CLINICAL MONITORING SYSTEM2Cleared 510(K)
- K001972ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK2Cleared 510(K)
- K000647DATEX-OHMEDA NETWORK AND CENTRAL2Cleared 510(K)
- K994430IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM2Cleared 510(K)
- K992749ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 918412Cleared 510(K)
- K992848ALARMVIEW SYSTEM2Cleared 510(K)
- K990378STATVIEW SYSTEM2Cleared 510(K)
- K982342DINAMAP MPS SELECT PORTABLE MONITOR2Cleared 510(K)
- K973527CARDIO-PAGER SYSTEM2Cleared 510(K)
- K973640TS2000 MEDICAL DEVICE MONITOR2Cleared 510(K)
- K973318MOBIMED SYSTEM, (PEGASUS AND POLARIS)2Cleared 510(K)
- K974101DATEX-ENGSTROM NETWORK2Cleared 510(K)
- K974567HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER2Cleared 510(K)
- K971868IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM2Cleared 510(K)
- K962473(VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY TRANSMITTERS AND ARRHYTMIA DETECTOR AND ALARMS WITH2Cleared 510(K)
- K972880MDP2000 MEDICAL DATA PROCESSOR2Cleared 510(K)
- K971683WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET2Cleared 510(K)
- K971569DINAMAP MPS PORTABLE MONITOR2Cleared 510(K)
- 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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Spire Health Remote Patient Monitoring System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K192952
- 510(k) Type
- Traditional
- Applicant
- Spire, Inc. d/b/a Spire Health
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/5/2020
- Days to Decision
- 228 days
- Submission Type
- Summary